Recall Z-1932-2012— Alere San Diego, Inc.

Name: FDA recall Z-1932-2012
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: K042890. Product: Triage D-dimer PN 98100 Used as an aid in the assessment and evaluation of patients suspected of having disseminated intravascular coagulation or thromboembolic events including pulmonary embolism.. 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

K042890 — TRIAGE D-DIMER TEST, MODEL 98100Biosite Incorporated·cleared 2004-11-29

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

Triage D-dimer PN 98100 Used as an aid in the assessment and evaluation of patients suspected of having disseminated intravascular coagulation or thromboembolic events including pulmonary embolism.

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.