Recall Z-2333-2021 ยท MVU Reagents, Specific, Analyte
Becton, Dickinson and Company, BD Biosciences
BD" Mouse IgG2a Isotype Control APC X39 ASR
| Date | Jul 22, 2021 |
| Status | Terminated |
| Reason | Complaints have been received for performance issues related to high background and staining. this issues is related to a manufacturing process error that can potentially cause a false positive staining due to contamination with another antibody. |
| Root cause | Nonconforming Material/Component |
| Action | On 07/22/2021, the firm sent an "URGENT MEDICAL DEVICE RECALL" Notification letter via FedEx to customers to inform them that the Recalling Firm received 3 complaints for performance issues related to high background and staining. Our investigation has confirmed there was an error during the manufacturing process that can potentially cause a false positive staining due to contamination with another antibody. Customers are instructed to: 1) Immediately review their inventory for the specific Catalog and lot number listed in the Recall Notification above. Destroy all product subject to the reca |
| Quantity | 23 reagents |
| Distribution | Worldwide distribution - U.S. Nationwide distribution in the states of CT, FL, KY, NY, and PA. The country of Taiwan. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.