Device 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.
Z-1148-2013
Product summary
- Event
- Event 64790
- Status
- Terminated
- Classification
- Class III
- Quantity
- 78 kits
- Official record key
device-enforcement:Z-1148-2013
Official wording
Reason: Alere San Diego is recalling the Clearview Mononucleosis Cassette because the positive control included in the rapid test may produce false negative results.
Code information: The affected control lot number is 11030386. Lot/Unit Codes: MON1040008 & MON1040016.
Distribution pattern: Nationwide Distribution including TN, WA, UT, KS, KY, MN, GA, MA, PA, NY, VT, and the Dist. of Columbia
Derived failure modes
-
Unknown
Alere San Diego is recalling the Clearview Mononucleosis Cassette because the positive control included in the rapid test may produce false negative results.