Recall Z-2271-2016
Alere San Diego, Inc. · initiated June 22, 2016
Class III – products unlikely to cause any adverse health reaction but that violate FDA labeling or manufacturing laws
Product
Signify Mono (Whole Blood, Serum, Plasma), Catalog No. 01P52-25 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.
Codes / lots: all lots are affected
Reason for recall
The Positive Control information referencing human plasma as the antibody material described in the product labeling and packaging is incorrect.
FDA-determined 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.
Details
- Recall number
- Z-2271-2016
- Initiated
- June 22, 2016
- Terminated
- January 29, 2018
- Product code
- KTN – System, Test, Infectious Mononucleosis
- Distribution
- US
- Recalling firm
- Alere San Diego, Inc., San Diego, CA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2265-2016 Class III | Acceava Mono II Rapid Test Strip (Whole Blood, Serum, Plasma), Catalog No. 92404.…The Positive Control information referencing human plasma as the antibody material described in the product… | 06/22/2016Terminated |
| Z-2266-2016 Class III | Cardinal Health Mono Rapid Test, Catalog No. B1077-28, a simple test that utilizes an…The Positive Control information referencing human plasma as the antibody material described in the product… | 06/22/2016Terminated |
| Z-2267-2016 Class III | Clearview MONO (Whole Blood, Serum, Plasma), Catalog No. 92401 a simple test that…The Positive Control information referencing human plasma as the antibody material described in the product… | 06/22/2016Terminated |
| Z-2268-2016 Class III | Henry Schein One Step + Mono Rapid Test Device, Catalog No. 9004070 a simple test that…The Positive Control information referencing human plasma as the antibody material described in the product… | 06/22/2016Terminated |
| Z-2269-2016 Class III | Proadvantage Mono Rapid Test Cassette, Catalog No. P080016 a simple test that utilizes…The Positive Control information referencing human plasma as the antibody material described in the product… | 06/22/2016Terminated |
| Z-2270-2016 Class III | Stanbio Rely Mono Rapid Test, Catalog No. 6200-010L and 6200-020L a simple test that…The Positive Control information referencing human plasma as the antibody material described in the product… | 06/22/2016Terminated |