FDA Class One Recall for Triage Diagnostics Tests (Multiple)–Potential For Increased Frequency of False Positive or False
Posted Jul 11 2012 6:08pm
The units recalled consist of a meter and various test devices that aid in the diagnosis of diseases and health conditions including heart failure and myocardial infarction. They can also be used to assess pulmonary embolism. The FDA states that all units recalled should be discarded and replacements may not be readily available to substitute, so in other words it sounds as though you could be out of luck to obtain immediate replacement units. Where’s the bar codes when we need them as this looks like a pretty substantial recall as the website states their products are used in 70% of US hospitals. BD
ISSUE: FDA notified healthcare professionals of a Class I Recall of Alere Triage products. Identified lots may have significantly decreased precision relative to the package insert, which could result in an increased frequency of false positive or false negative results. These false positive and false negative results are unpredictable within lots and may not be detected by Quality Control testing.
Certain lots affected have an increased frequency of Troponin I results >0.05 ng/mL for samples which are found to be below 0.05 ng/mL upon additional testing.
There have been reports of patients receiving inappropriate clinical management which may have been due to such erroneous results. This product may cause serious adverse health consequences, including death.
These products were manufactured from 06/12/2011 to 04/08/2012. Distributed from 09/08/2011 to 06/05/2012. 98,100 test kits have the potential to be defective. See the Recall Notice for listings of identified Lot Numbers.