Recall Z-2268-2016 ยท KTN System, Test, Infectious Mononucleosis
Alere San Diego, Inc.
Henry Schein One Step + Mono Rapid Test Device, Catalog No. 9004070 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.
| Date | Jun 22, 2016 |
| Status | Terminated |
| Reason | The Positive Control information referencing human plasma as the antibody material described in the product labeling and packaging is incorrect. |
| Root cause | Unknown/Undetermined by firm |
| Action | 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 |
| Distribution | US |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K042272 | ACON MONONUCLEOSIS RAPID TEST STRIP (WHOLE BLOOD/SERUM/PLASMA) ACON Laboratories, Inc., Feb 28, 2005 |