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.
Reported: July 18, 2012 Initiated: May 22, 2012 #Z-1929-2012
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.
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.
Details
- Recalling Firm
- Alere San Diego, Inc.
- Units Affected
- 6,044 kits
- Distribution
- Nationwide Distribution
- Location
- San Diego, CA
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Alere San Diego, Inc.. Units affected: 6,044 kits.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 18, 2012. Severity: Critical. Recall number: Z-1929-2012.
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