FDA Enforcement
Class III
Terminated
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.
Recall: Z-1148-2013
·
Reported April 24, 2013
Enforcement
- Recall Number
- Z-1148-2013
- Event ID
- 64790
- Classification
- Class III
- Status
- Terminated
- Product Type
- Devices
- Firm
- Alere San Diego, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- April 24, 2013
- Initiation Date
- February 26, 2013
- Classification Date
- April 18, 2013
- Termination Date
- August 29, 2013
- Address
- 9975 Summers Ridge Rd, N/A, San Diego, CA, 92121-2997, United States
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
Alere San Diego is recalling the Clearview Mononucleosis Cassette because the positive control included in the rapid test may produce false negative results.
Code Info
The affected control lot number is 11030386. Lot/Unit Codes: MON1040008 & MON1040016.
Distribution
Nationwide Distribution including TN, WA, UT, KS, KY, MN, GA, MA, PA, NY, VT, and the Dist. of Columbia
Quantity
78 kits