Recall Z-1928-2012— Alere San Diego, Inc.
Class I · Terminated
Class I FDA medical device recall by Alere San Diego, Inc., initiated 2012-05-22, terminated 2013-10-18. It names one FDA 510(k) clearance: K080269. Product: Alere Triage CardioProfiler Panel PN 97100CP Used for the quantitative determination of creatine kinase MB, myoglobin, troponin I and B-type natriuretic peptide in EDTA anticoagulated whole blood and 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..
- Recalling firm
- Alere San Diego, Inc.
- Classification
- Class I
- Status
- Terminated
- Initiated
- 2012-05-22
- Terminated
- 2013-10-18
- Firm location
- San Diego, CA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Alere Triage CardioProfiler Panel PN 97100CP Used for the quantitative determination of creatine kinase MB, myoglobin, troponin I and B-type natriuretic peptide in EDTA anticoagulated whole blood and 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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.