Stanbio Rely Mono Rapid Test, Catalog No. 6200-010L and 6200-020L a simple test that utilizes an extract of bovine erythrocytes to qualitatively and selectively detect IM heterophile antibodies in whole blood, serum or plasma in just minutes.
- Company
- Alere San Diego, Inc.
- Recall Initiated
- June 22, 2016
- Terminated
- January 29, 2018
- Recall Number
- Z-2270-2016
- Firm Location
- San Diego, CA
Reason for Recall
The Positive Control information referencing human plasma as the antibody material described in the product labeling and packaging is incorrect.
Distribution
US
Lot / Code Info
all lots are affected
Root Cause
Unknown/Undetermined by firm
Action Taken
A Medical Device Correction letter dated 6/22/16 will be sent to all customers to inform them that Alere is recalling the MONO Rapid Test products because the Positive Control Information referencing human plasma as the antibody material described in the product labeling and packaging is incorrect. Customers are informed that the labeling states the Positive Control contains the following: Diluted human plasma containing IM heterophile antibodies, 0.09% sodium azide. The Positive Control contains the following: Goat anti-mono antibody, 0.09% sodium azide. Customers are instructed to complete and fax or email the enclosed verification form within 10 days. Customers with questions are instructed to contact Alere San Diego at (844) 804-4945 or email at verfications.ts@alere.com.