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U.S. Department of Health and Human Services

Enforcement Report - Week of July 18, 2012

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Product Detail

Product Description Alere Triage Cardiac Panel PN 97000HS Used for the quantitative determination of creatine kinase MD (CK--MB), myoglobin and troponin I in EDTA anticoagulated whole blood or plasma specimens.
Recall Number Z-1929-2012
Classification Class I
Code Info Phase 1: K50514B, W49753B, W49754B, W49756B, W49757B, W49758B, W49760B, W49761B, W49762B, W49764B, W49767B, W49768B, W49769B, W49770B, W50608B, W50613B, W50621B, W50623B, W50625B, W50632B, W50634B, W50637B, W50639B, W50641B, W50642B, W51114B, and W51119B. Phase 2: W49766B, W50605B, W50627B, W50628B, and W50629B.
Product Distributed Qty 6,044 kits
Reason For Recall 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.

Event Detail

Event Id 61927
Product Type Devices
Status Ongoing
Recalling Firm Alere San Diego, Inc.
City San Diego
State CA
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-05-22
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Nationwide Distribution
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