Recall Z-2023-2024
Becton Dickinson & Co. · initiated May 7, 2024
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
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.
Codes / lots: Catalog No. 445003-01; UDI-DI: (01) 60382904450030 (17) 240803 (10) 3291356 (20) 01 (30) 1, (01) 60382904450030 (17) 241119 (10) 3291358 (20) 01 (30) 1, (01) 60382904450030 (17) 241217 (10) 3326001 (20) 01 (30) 1; Lot No. 3291356 (Exp. 8/3/24), 3291358 (Exp. 11/19/24), 3326001 (Exp. 12/17/24).
Reason for recall
Assays may produce false negative results due to decreased activity of the enzyme utilized in manufacturing.
FDA-determined cause: Component design/selection
Action taken
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@bd.com; consignees with any recall related questions can email BDRC22@bd.com.
Details
- Recall number
- Z-2023-2024
- Initiated
- May 7, 2024
- Posted by FDA
- June 5, 2024
- Product code
- QJR – Reagents, 2019-Novel Coronavirus Nucleic Acid
- Quantity
- 2,061 kits
- Distribution
- Domestic: Nationwide Distribution; Foreign: AU, BR, BE, CA, CO, & JP.
- Recalling firm
- Becton Dickinson & Co., Sparks, MD