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.
- Company
- Alere San Diego, Inc.
- Recall Initiated
- February 26, 2013
- Posted
- April 18, 2013
- Terminated
- August 29, 2013
- Recall Number
- Z-1148-2013
- Quantity
- 78 kits
- Firm Location
- San Diego, CA
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.
Distribution
Nationwide Distribution including TN, WA, UT, KS, KY, MN, GA, MA, PA, NY, VT, and the Dist. of Columbia
Lot / Code Info
The affected control lot number is 11030386. Lot/Unit Codes: MON1040008 & MON1040016.
Root Cause
Material/Component Contamination
Action Taken
Alere sent an Urgent Medical Device Recall letter dated February 26, 2013, to all affected customers. The letter informs the customers of the problems identified and the actions to be taken. Customers with unused product remaining are instructed to immediately discard it. Investigations of customer complaints indicate that the positive control included with this lot may produce false negative results. Customers are instructed to return the attached Verification form. Customers that have consumed all product are instructed to indicate zero under "Quantity Discarded" and complete and fax back the form. Replacement product will be provided for any unused portion of the affected lot based on completion and return of the attached Verification Form. Customers with any questions are instructed to contact Alere Technical Services at (866) 216-0094 or by email at later.flow.support@alere.com. For questions regarding this recall call 858-805-2000, ext 3015.