Proadvantage Mono Rapid Test Cassette, Catalog No. P080016 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.
Recall
- Recall Number
- Z-2269-2016
- Event Number
- 74505
- Firm
- Alere San Diego, Inc.
- FEI Number
- 1000125596
- Product Code
- KTN
- Status
- Terminated
- Root Cause
- Unknown/Undetermined by firm
- Initiated
- June 22, 2016
- Terminated
- January 29, 2018
- Address
- 9975 Summers Ridge Rd, San Diego, CA, 92121-2997
Description
Proadvantage Mono Rapid Test Cassette, Catalog No. P080016 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.
The Positive Control information referencing human plasma as the antibody material described in the product labeling and packaging is incorrect.
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 [email protected].
US