FDAFDA · Food and drugs·Recall number Z-1148-2013
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.
Published April 24, 2013 · Recall initiated: February 26, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Alere San Diego is recalling the Clearview Mononucleosis Cassette because the positive control included in the rapid test may produce false negative results.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Alere San Diego, Inc.
- Distributor
- Nationwide Distribution including TN, WA, UT, KS, KY, MN, GA, MA, PA, NY, VT, and the Dist. of Columbia
- Lot
- The affected control lot number is 11030386. Lot/Unit Codes: MON1040008 & MON1040016.
- Risk classification
- Class III
- Area (FDA)
- device
- Country
- United States
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.