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.
Reported: April 24, 2013 Initiated: February 26, 2013 #Z-1148-2013
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.
Details
- Recalling Firm
- Alere San Diego, Inc.
- Units Affected
- 78 kits
- Distribution
- Nationwide Distribution including TN, WA, UT, KS, KY, MN, GA, MA, PA, NY, VT, and the Dist. of Columbia
- Location
- San Diego, CA
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Alere San Diego, Inc.. Units affected: 78 kits.
Why was this product recalled? ▼
Alere San Diego is recalling the Clearview Mononucleosis Cassette because the positive control included in the rapid test may produce false negative results.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 24, 2013. Severity: Low. Recall number: Z-1148-2013.
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