Z-2162-2025Class II

BD COR System Software. Model Number: 444829

Name: Z-2162-2025 BD COR System Software. Model Number: 444829
Creator: Becton Dickinson & Co.
Published: 2025-06-23
License: https://open.fda.gov/license/

Becton Dickinson & Co / initiated 2025-06-23 / Open, Classified / root cause: labeling and UDI

FDA source

Becton Dickinson & Co. began a recall of BD COR System Software. Model Number: 444829 on 2025-06-23. FDA classified it as Class II and gives the reason as "Potential for functionality issue that supports the Over labeling feature and could lead to possible false negative results". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2162-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-06-23
Posted: 2025-07-23
Recalling firm: Becton Dickinson & Co
Product: BD COR System Software. Model Number: 444829.
Product code: MAQ Kit, Dna Detection, Human Papillomavirus
Reason for recall: Potential for functionality issue that supports the Over labeling feature and could lead to possible false negative results.
Root cause tag: labeling and UDI
FDA root cause: Under Investigation by firm
Action: Becton, Dickinson and Company began notification of consignees on about 06/23/2025 via telephone call and followed by a letter. Consignees were instructed to note the outlined workflows when loading specimens with the Over labeling feature enabled and consider retesting affected specimens for HPV testing if affected. Consignees were also instructed to post the notification within their facility, notify customers if affected units were further distributed, and complete and return the provided Customer Response Form.
Quantity in commerce: 7 systems
Distribution: Worldwide - US Nationwide distribution in the states of Florida, Texas and Michigan. The countries of Sweden and Belgium.
Product codes and lots: Model Number: 444829. UDI-DI: 00382904448295. Software version 8.80 and above.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2162-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2162-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-07-30	2025-07-23

Product code MAQ

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)