Recall Z-2023-2024 ยท QJR Reagents, 2019-Novel Coronavirus Nucleic Acid
Becton Dickinson & Co.
BD SARS-CoV-2 Reagents for BD MAX" Systems. RT-PCR test to detect SARS-CoV-2 in nasal, nasopharyngeal, oropharyngeal swab specimens, and saliva specimens.
| Date | Jun 5, 2024 (initiated May 7, 2024) |
| Status | Open, Classified |
| Reason | Assays may produce false negative results due to decreased activity of the enzyme utilized in manufacturing. |
| Root cause | Component design/selection |
| Action | Consignees were mailed and/or emailed an URGENT: Medical Device Product Correction notification, dated 5/7/24. The notification instructs consignees to immediately inspect their inventory for affected devices and destroy them per the consignee's destruction process, ensure the notification is read and understood, disseminate the notification to among those in your organization and customers who should be made aware, and return the completed Response Form to BD by email to BDRC22@bd.com or by fax to 312-949-0438. Consignees with any complaints can call 1-844-823-5433 or email productcomplaints@ |
| Quantity | 2,061 kits |
| Distribution | Domestic: Nationwide Distribution; Foreign: AU, BR, BE, CA, CO, & JP. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.