Recall Z-1929-2012— Alere San Diego, Inc.

Name: FDA recall Z-1929-2012
Creator: U.S. Food and Drug Administration
Published: 2012-05-22

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: K030286. 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..

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 record

K030286 — TRIAGE CARDIO PROFILER/TRIAGE CARDIAC PANELBiosite Incorporated·cleared 2003-02-21

K-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 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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.