BD SARS-CoV-2 Reagents for BD MAX" Systems. RT-PCR test to detect SARS-CoV-2 in nasal, nasopharyngeal, oropharyngeal swa

FDA device recall Z-2023-2024 · posted 2024-06-05 · Open, Classified

Recall details

Recalling firm

Becton Dickinson & Co.

Reason for recall

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

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.

Root cause

Component design/selection

Status

Open, Classified

Product code

QJR

Quantity affected

2,061 kits

Distribution

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

Date initiated

2024-05-07

Date posted

2024-06-05

Location

Sparks, MD