BD COR System Software. Model Number: 444829 recallZ-2162-2025 · Becton Dickinson & Co. · initiated Jun 23, 2025
Class II Open, Classified All recalls posted in July 2025
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Becton Dickinson & Co. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Potential for functionality issue that supports the Over labeling feature and could lead to possible false negative results.
FDA root cause category: Under Investigation by firm
What the company is doing
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.
Recall details
- Recall number
- Z-2162-2025
- Recall class
- Class II
- Status
- Open, Classified
- Initiated by the company
- Jun 23, 2025
- Posted by the FDA
- Jul 23, 2025
- Recalling firm
- Becton Dickinson & Co.
- Quantity
- 7 systems
- Product code
- MAQ
- FDA submissions
- P160037
- Distribution
- Worldwide - US Nationwide distribution in the states of Florida, Texas and Michigan. The countries of Sweden and Belgium.
Product description
BD COR System Software. Model Number: 444829.
Code information (models, lots, serial numbers)
Model Number: 444829. UDI-DI: 00382904448295. Software version 8.80 and above.
Other devices under the same FDA submission
5 devices cleared under P160037 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- BD COR™ GX INSTRUMENT 443990Becton, Dickinson And Company · KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS1 recall22 reports
- BD COR™ PX INSTRUMENT 443988Becton, Dickinson And Company · KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS1 recall4 reports
- BD Onclarity™ HPV Assay Reagent Pack 441990Becton, Dickinson And Company · KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS8 reports
- BD Onclarity™ HPV SurePath™ Diluent Tubes 445329Becton, Dickinson And Company · KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS3 reports
- BD Onclarity™ HPV Assay Reagent Pack 444075Becton, Dickinson And Company · KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS2 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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