Fleishman-Hillard
Kimberly Mays
Tel: +1 919-620-2937
kimberly.mays@fleishman.com
FOR IMMEDIATE RELEASE - October 27, 2010 - DURHAM, N.C. - bioMérieux, Inc. on September 16, 2010, initiated a worldwide voluntary product correction of VITEK® 2 Gram Negative Susceptibility Cards containing the antibiotic Piperacillin/Tazobactam (TZPv). These cards, manufactured after March 10, 2009, are used in clinical laboratories to perform antimicrobial susceptibility testing as part of the VITEK® System. Clinical laboratories were notified to perform an alternative method of testing prior to reporting results for:
- Piperacillin/Tazobactam (TZPvv) and Escherichia coli results
- Piperacillin/Tazobactam (TZPvv) and Klebsiella pneumoniae with resistant results
bioMérieux also provided instructions to implement suppression rules to prevent inappropriate reporting of results. Customers can continue to use the VITEK® 2 cards following the guidelines above.
An internal investigation by bioMérieux confirmed user reports that VITEK® 2 antimicrobial susceptibility testing may incorrectly report E. coli and K. pneumoniae susceptible isolates as resistant to Piperacillin/Tazobactam (TZPv). This same investigation also found that E. coli isolates resistant to Piperacillin/Tazobactam (TZPv) may be incorrectly identified as susceptible
Incorrect results could potentially lead to patients being inappropriately treated with Piperacillin/Tazobactam when infected with a resistant E. coli isolate. There have been no reports to date of treatment failures associated with either falsely-resistant or falsely-susceptible E. coli results for Piperacillin/Tazobactam (TZPv), or for falsely-resistant K. pneumoniae results.
Attached below is a list of VITEK® 2 cards that are affected by this product correction. Of these affected cards, all lot numbers currently in distribution, as well as future distribution are affected until further notice. In addition, all new VITEK® 2 cards created that contain TZPv are affected by this product correction.
bioMérieux has notified the U.S. Food and Drug Administration (FDA) and is working closely with the agency regarding this urgent product correction. Laboratories with questions should contact bioMérieux, Inc. at 1-800-682-2666, option 3, 24 hours a day; physicians should contact their clinical diagnostics laboratory for additional information if necessary. Consumers with questions should contact their physician.
Adverse reactions or quality problems experienced with the use of the cards should be reported to bioMérieux by contacting Customer Service at 1-800-682-2666, option 3. Customers may also report adverse reactions or quality problems through FDA’s MedWatch Adverse Event Reporting program either online at www.fda.gov/medwatch/report.htm ; by regular mail using the postage-paid, pre-addressed Form FDA 3500 available at: www.fda.gov/medwatch/getforms.htm ; or by fax at 1-800-FDA-0178.
A world leader in the field of in vitro diagnostics for over 45 years, bioMérieux is present in more than 150 countries through 39 subsidiaries and a large network of distributors. bioMérieux provides diagnostic solutions (reagents, instruments, software) which determine the source of disease and contamination to improve patient health and ensure consumer safety. Our products are used for diagnosing infectious diseases and providing high medical value results for cancer screening and monitoring and cardiovascular emergencies. They are also used for detecting microorganisms in agri-food, pharmaceutical and cosmetic products. Other information can be found at www.biomerieux.com
VITEK® 2 TZPv Affected Cards Card Name
Ref. #
Card Name
Ref. #
Card Name
Ref. #
Card Name
Ref. #
AST-N080 | 22214 | | AST-N117
22290
| AST-N152
22347
| AST-GN22 | 22227 | AST-N081 | 22215 | | AST-N118
22291
| AST-N153
22348
| AST-GN23 | 22228 | AST-N082 | 22217 | | AST-N120
22293
| AST-N155
22352
| AST-GN24 | 22229 | AST-N084 | 22224 | | AST-N121
22295
| AST-N156
22353
| AST-GN25 | 22230 | AST-N085 | 22225 | | AST-N122
22299
| AST-N157
22354
| AST-GN26 | 22244 | AST-N086 | 22234 | | AST-N123
22301
| AST-N158
22355
| AST-GN27 | 22245 | AST-N087 | 22235 | | AST-N124
22303
| AST-N159
22356
| AST-GN28 | 22254 | AST-N088 | 22236 | | AST-N127
22308
| AST-N160
22357
| AST-GN29 | 22266 | AST-N089 | 22237 | | AST-N128
22309
| AST-N161
410026
| AST-GN30 | 22267 | AST-N090 | 22240 | | AST-N129
22310
| AST-N162
410023
| AST-GN31 | 22268 | AST-N091 | 22241 | | AST-N130
22311
| AST-N163
410084
| AST-GN32 | 22269 | AST-N093 | 22243 | | AST-N131
22315
| AST-N164
410101
| AST-GN33 | 22270 | AST-N093 | 22246 | | AST-N132
22316
| AST-N165
410102
| AST-GN34 | 22271 | AST-N094 | 22247 | | AST-N133
22318
| AST-N166
410136
| AST-GN35 | 22286 | AST-N095 | 22249 | | AST-N134
22319
| AST-N167
410138
| AST-GN36 | 22300 | AST-N096 | 22250 | | AST-N135
22322
| AST-N168
410139
| AST-GN37 | 22312 | AST-N097 | 22251 | | AST-N136
22323
| AST-N170
410222
| AST-GN39 | 22337 | AST-N098 | 22253 | | AST-N137
22324
| AST-N171
410249
| AST-GN40 | 410756 | AST-N100 | 22256 | | AST-N138
22326
| AST-N172
410298
| AST-GN41 | 410757 | AST-N103 | 22259 | | AST-N139
22327
| AST-N174
410404
| AST-GN42 | 410758 | AST-N104 | 22261 | | AST-N140
22328
| AST-N175
410403
| AST-GN43 | 410759 | AST-N105 | 22262 | | AST-N141
22329
| AST-N176
410402
| AST-GN44 | 410805 | AST-N106 | 22264 | | AST-N142
22332
| AST-N177
410392
| | | AST-N107 | 22265 | | AST-N143
22333
| AST-N178
410393
| | | AST-N108 | 22272 | | AST-N144
22334
| AST-N179
410640
| | | AST-N109 | 22273 | | AST-N145
22338
| AST-N180
410771
| | | AST-N110 | 22274 | | AST-N146
22341
| AST-N181
410803
| | | AST-N111 | 22275 | | AST-N147
22342
| AST-N182
410804
| | | AST-N112 | 22281 | | AST-N148
22343
|
| | | AST-N114 | 22283 | | AST-N149
22344
|
| | | AST-N115 | 22285 | | AST-N150
22345
|
| | | AST-N116 | 22289 | | AST-N151
22346
|
| | |
Fleishman-Hillard
Kimberly Mays
Tel: +1 919-620-2937
kimberly.mays@fleishman.com
FOR IMMEDIATE RELEASE - October 27, 2010 - DURHAM, N.C. - bioMérieux, Inc. on September 16, 2010, initiated a worldwide voluntary product correction of VITEK® 2 Gram Negative Susceptibility Cards containing the antibiotic Piperacillin/Tazobactam (TZPv). These cards, manufactured after March 10, 2009, are used in clinical laboratories to perform antimicrobial susceptibility testing as part of the VITEK® System. Clinical laboratories were notified to perform an alternative method of testing prior to reporting results for:
bioMérieux also provided instructions to implement suppression rules to prevent inappropriate reporting of results. Customers can continue to use the VITEK® 2 cards following the guidelines above.
An internal investigation by bioMérieux confirmed user reports that VITEK® 2 antimicrobial susceptibility testing may incorrectly report E. coli and K. pneumoniae susceptible isolates as resistant to Piperacillin/Tazobactam (TZPv). This same investigation also found that E. coli isolates resistant to Piperacillin/Tazobactam (TZPv) may be incorrectly identified as susceptible
Incorrect results could potentially lead to patients being inappropriately treated with Piperacillin/Tazobactam when infected with a resistant E. coli isolate. There have been no reports to date of treatment failures associated with either falsely-resistant or falsely-susceptible E. coli results for Piperacillin/Tazobactam (TZPv), or for falsely-resistant K. pneumoniae results.
Attached below is a list of VITEK® 2 cards that are affected by this product correction. Of these affected cards, all lot numbers currently in distribution, as well as future distribution are affected until further notice. In addition, all new VITEK® 2 cards created that contain TZPv are affected by this product correction.
bioMérieux has notified the U.S. Food and Drug Administration (FDA) and is working closely with the agency regarding this urgent product correction. Laboratories with questions should contact bioMérieux, Inc. at 1-800-682-2666, option 3, 24 hours a day; physicians should contact their clinical diagnostics laboratory for additional information if necessary. Consumers with questions should contact their physician.
Adverse reactions or quality problems experienced with the use of the cards should be reported to bioMérieux by contacting Customer Service at 1-800-682-2666, option 3. Customers may also report adverse reactions or quality problems through FDA’s MedWatch Adverse Event Reporting program either online at www.fda.gov/medwatch/report.htm ; by regular mail using the postage-paid, pre-addressed Form FDA 3500 available at: www.fda.gov/medwatch/getforms.htm ; or by fax at 1-800-FDA-0178.
A world leader in the field of in vitro diagnostics for over 45 years, bioMérieux is present in more than 150 countries through 39 subsidiaries and a large network of distributors. bioMérieux provides diagnostic solutions (reagents, instruments, software) which determine the source of disease and contamination to improve patient health and ensure consumer safety. Our products are used for diagnosing infectious diseases and providing high medical value results for cancer screening and monitoring and cardiovascular emergencies. They are also used for detecting microorganisms in agri-food, pharmaceutical and cosmetic products. Other information can be found at www.biomerieux.com
VITEK® 2 TZPv Affected CardsCard Name
Ref. #
Card Name
Ref. #
Card Name
Ref. #
Card Name
Ref. #
AST-N080
22214
AST-N117
22290
AST-N152
22347
AST-GN22
22227
AST-N081
22215
AST-N118
22291
AST-N153
22348
AST-GN23
22228
AST-N082
22217
AST-N120
22293
AST-N155
22352
AST-GN24
22229
AST-N084
22224
AST-N121
22295
AST-N156
22353
AST-GN25
22230
AST-N085
22225
AST-N122
22299
AST-N157
22354
AST-GN26
22244
AST-N086
22234
AST-N123
22301
AST-N158
22355
AST-GN27
22245
AST-N087
22235
AST-N124
22303
AST-N159
22356
AST-GN28
22254
AST-N088
22236
AST-N127
22308
AST-N160
22357
AST-GN29
22266
AST-N089
22237
AST-N128
22309
AST-N161
410026
AST-GN30
22267
AST-N090
22240
AST-N129
22310
AST-N162
410023
AST-GN31
22268
AST-N091
22241
AST-N130
22311
AST-N163
410084
AST-GN32
22269
AST-N093
22243
AST-N131
22315
AST-N164
410101
AST-GN33
22270
AST-N093
22246
AST-N132
22316
AST-N165
410102
AST-GN34
22271
AST-N094
22247
AST-N133
22318
AST-N166
410136
AST-GN35
22286
AST-N095
22249
AST-N134
22319
AST-N167
410138
AST-GN36
22300
AST-N096
22250
AST-N135
22322
AST-N168
410139
AST-GN37
22312
AST-N097
22251
AST-N136
22323
AST-N170
410222
AST-GN39
22337
AST-N098
22253
AST-N137
22324
AST-N171
410249
AST-GN40
410756
AST-N100
22256
AST-N138
22326
AST-N172
410298
AST-GN41
410757
AST-N103
22259
AST-N139
22327
AST-N174
410404
AST-GN42
410758
AST-N104
22261
AST-N140
22328
AST-N175
410403
AST-GN43
410759
AST-N105
22262
AST-N141
22329
AST-N176
410402
AST-GN44
410805
AST-N106
22264
AST-N142
22332
AST-N177
410392
AST-N107
22265
AST-N143
22333
AST-N178
410393
AST-N108
22272
AST-N144
22334
AST-N179
410640
AST-N109
22273
AST-N145
22338
AST-N180
410771
AST-N110
22274
AST-N146
22341
AST-N181
410803
AST-N111
22275
AST-N147
22342
AST-N182
410804
AST-N112
22281
AST-N148
22343
AST-N114
22283
AST-N149
22344
AST-N115
22285
AST-N150
22345
AST-N116
22289
AST-N151
22346