Recall Z-1148-2013— Alere San Diego, Inc.

Name: FDA recall Z-1148-2013
Creator: U.S. Food and Drug Administration
Published: 2013-02-26

Class III · Terminated

Class III FDA medical device recall by Alere San Diego, Inc., initiated 2013-02-26, terminated 2013-08-29. It names one FDA 510(k) clearance: K042272. Product: IMO-402 Mononucleosis Rapid Test Device (Whole Blood/Serum/Plasma). Catalog #IMO-402/94201 The MONO test (Whole Blood) is a rapid chromatographic immunoassay for the qualitative detection of Infectious Mononucleosis heterophile antibodies in whole blood to aid in the diagnosis of infectious Mononucleosis.. Reason: Alere San Diego is recalling the Clearview Mononucleosis Cassette because the positive control included in the rapid test may produce false negative results..

Recalling firm: Alere San Diego, Inc.
Classification: Class III
Status: Terminated
Initiated: 2013-02-26
Terminated: 2013-08-29
Firm location: San Diego, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K042272 — ACON MONONUCLEOSIS RAPID TEST STRIP (WHOLE BLOOD/SERUM/PLASMA)ACON Laboratories, Inc.·cleared 2005-02-28

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

IMO-402 Mononucleosis Rapid Test Device (Whole Blood/Serum/Plasma). Catalog #IMO-402/94201 The MONO test (Whole Blood) is a rapid chromatographic immunoassay for the qualitative detection of Infectious Mononucleosis heterophile antibodies in whole blood to aid in the diagnosis of infectious Mononucleosis.

Reason for recall

Alere San Diego is recalling the Clearview Mononucleosis Cassette because the positive control included in the rapid test may produce false negative results.

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