Z-2023-2024Class II

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

Name: Z-2023-2024 BD SARS-CoV-2 Reagents for BD MAX" Systems. RT-PCR test to detect SARS-CoV-2 in nasal, nasopharyngeal...
Creator: Becton Dickinson & Co.
Published: 2024-05-07
License: https://open.fda.gov/license/

Becton Dickinson & Co / initiated 2024-05-07 / Open, Classified / root cause: design

FDA source

Becton Dickinson & Co. began a recall of 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 on 2024-05-07. FDA classified it as Class II and gives the reason as "Assays may produce false negative results due to decreased activity of the enzyme utilized in manufacturing". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-2023-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-05-07
Posted: 2024-06-05
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.
Product code: QJR Reagents, 2019-Novel Coronavirus Nucleic Acid
Reason for recall: Assays may produce false negative results due to decreased activity of the enzyme utilized in manufacturing.
Root cause tag: design
FDA 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 [email protected] or by fax to 312-949-0438. Consignees with any complaints can call 1-844-823-5433 or email [email protected]; consignees with any recall related questions can email [email protected].
Quantity in commerce: 2,061 kits
Distribution: Domestic: Nationwide Distribution; Foreign: AU, BR, BE, CA, CO, & JP.
Product codes and 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).

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2023-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2023-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-06-12	2024-06-05

Product code QJR

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)