FDA Medical Device Recalls (openFDA)
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.
- Recall number
- Z-2023-2024
- Recalling firm
- Becton Dickinson & Co.
- 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.
- Status
- Open, Classified
- Initiated
- 2024-05-07
- Posted
- 2024-06-05
- Terminated
- not on file
- 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@bd.com; consignees with any recall related questions can email BDRC22@bd.com.
- Quantity
- 2,061 kits
- Distribution
- Domestic: Nationwide Distribution; Foreign: AU, BR, BE, CA, CO, & JP.
- Lot, serial or model codes
- 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).
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- QJR
- Firm FEI
- 1119779
- Firm city
- Sparks
- Firm state
- MD
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28