Alere Triage Profiler SOB Panel PN 97300 Used for the determination of creatine kinase MB, myoglobin, troponin I, B-type

FDA device recall Z-1930-2012 · posted 2012-07-06 · Terminated

Recall details

Recalling firm

Alere San Diego, Inc.

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.

Action taken

Phase 1 of the recall included a recall communication being initiated on May 22, 2012 with Alere forwarding a recall letter to all their customers who purchased the Triage CardioProfiler Panel, Triage Cardiac Panel, Triage Profiler SOB Panel, Triage BNP, and Triage D-dimer. The letter informed the customers of the problems identified and the actions to be taken. Customers were instructed to discontinue use of the affected product, and to complete and fax the enclosed verification form within 10 days. Phase 2 of the recall included a recall communication letter being forwarded to customers on 6/11/12. The second letter included additional lots of Triage products that go beyond the lots included in an earlier recall notification letter. The letter informed the customers that the additional lots have significantly decreased precision relative to the package insert which could result in an increased frequency of false positive or false negative results. A third letter dated June 12, 2012 included 3 more lots for the Triage Cardio Profiler Panel PN 97100CP and Alere Triage Profiler SOB Panel PN 97300. The letter informed the customers that the additional lots 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. Customers with questions about the information contained in the notifications, were instructed to contact Alere San Diego at (877) 308-8287 or at 9975 Summers Ridge Road, San Diego, CA 92121.

Root cause

Process design

Status

Terminated

Product code

DAP

Quantity affected

5,013 kits

Distribution

Nationwide Distribution

Date initiated

2012-05-22

Date posted

2012-07-06

Date terminated

2013-10-18

Location

San Diego, CA

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