Alere Triage CardioProfiler Panel PN 97100CP Used for recall
Alere Triage CardioProfiler Panel PN 97100CP Used for the quantitative determination of creatine kinase MB, myoglobin, troponin I and B-type…
Why was Alere Triage CardioProfiler Panel PN 97100CP Used for recalled?
Certain lots of the affected products 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Phase 1: W49604B, W49606B, W49607B, W49611B, W49612B, W49613B, W49614B, W49615B, W49616B, W49617B, W49620B, W49622B, W49623B, W49624B, W49625B, W49627B, W49628B, W49629B, W49630B, W49631B, W49633B, W49634B, W49635B, W49638B, W49639B, W50726B, W50727B, W50728B, W50731B, W50733B, W50734B, W50738B, and W50739B. Phase 2: W49609B, W49610B, W49618B, W49619B, W49626B, W49632B, W49640B, W50737B, and W50744B.
- Product
- Alere Triage CardioProfiler Panel PN 97100CP Used for the quantitative determination of creatine kinase MB, myoglobin, troponin I and B-type…
- Recalling firm
- Alere San Diego, Inc.
- Quantity
- 16,962 kits
- Distribution
- Nationwide Distribution
- Recall date
- July 18, 2012
- Classification
- Class I
- Status
- Terminated
- Agency
- FDA (device)