—#207672

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.

FDA product code: QJR — Reagents, 2019-Novel Coronavirus Nucleic Acid
Device class: Class N
Medical specialty: Unknown
Affected lot / code info: 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).

Why it was recalled

Assays may produce false negative results due to decreased activity of the enzyme utilized in manufacturing.

Root cause (FDA determination)

Component design/selection

Action the firm took

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.

Recalling firm

Firm: Becton Dickinson & Co.
Address: 7 Loveton Cir, Sparks, Maryland 21152-9212

Distribution

Distribution pattern: Domestic: Nationwide Distribution; Foreign: AU, BR, BE, CA, CO, & JP.

Timeline

Recall initiated: 2024-05-07
Posted by FDA: 2024-06-05
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #207672. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.