FDA Device recall Z-1929-2012
Alere Triage Cardiac Panel PN 97000HS Used for the quantitative determination of creatine kinase MD (CK--MB), myoglobin and troponin I in E…
- FDA Device
- Class I
- terminated
- Published 2012-07-18
On 2012-07-18 the FDA classified a Class I recall of Alere Triage Cardiac Panel PN 97000HS Used for the quantitative determination of creatine kinase MD (CK--MB), myoglobin and troponin I in E… by Alere San Diego, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1929-2012 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2012-05-22 |
| Published | 2012-07-18 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Alere San Diego |
| Distribution | US |
Product
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.
Reason
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.
Identifiers
| code_info | Phase 1: K50514B, W49753B, W49754B, W49756B, W49757B, W49758B, W49760B, W49761B, W49762B, W49764B, W49767B, W49768B,…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. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1929-2012%22
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