BD COR™ PX INSTRUMENT 443988Recalls & reported problems
Becton, Dickinson And Company · BD COR PX INSTRUMENT · Class 3
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00382904439880), received between Oct 15, 2025 and Jan 20, 2026 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Computer Operating System Problem” (3 reports).
1 FDA recall record name this device's identifier, 1 still open.
1 other recall cover devices cleared under the same FDA submission (P160037); they may or may not involve this specific model.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Recalls naming this device
- Oct 31, 2024Class IIOpen, Classified
BD confirmed that product service credentials used by some BD technical support teams to access certain BD products were accessed by an unauthorized actor. Until these product service credentials are updated, there is a risk of unauthorized access that may impact the confidentiality, integrity and/or availability of the relevant products and associated data.
Z-0587-2025 · Root cause: Software design · Recall details · FDA record ↗
Most reported problems
Device problems
- Computer Operating System Problem3
- Mechanical Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions4
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 20, 2026Computer Operating System Problem
IT WAS REPORTED WHILE USING BD COR PX, THERE WAS A LOSS OF CHAIN OF CUSTODY WITH THE SAMPLE RACK. NO ADVERSE IMPACT OR MIS-ASSOCIATION OF SAMPLES WERE REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24115327 ↗MalfunctionNov 4, 2025Mechanical Problem; Mechanical Problem
IT WAS REPORTED THAT WHILE USING THE BD COR¿ PX INSTRUMENT, THE ROBOT ARM CONTINUED TO MOVE AND FUNCTION WHILE THE DOOR WAS OPENED. THERE WAS NO REPORT OF ADVERSE IMPACT TO THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23467063 ↗MalfunctionOct 15, 2025Computer Operating System Problem; Computer Operating System Problem
IT WAS REPORTED THAT AFTER TESTING ON THE BD COR PX INSTRUMENT, A SOFTWARE ERROR OCCURRED WITH THE OVER-LABELING FUNCTION IN THE WORKFLOW. WHILE THIS ISSUE WAS BEING INVESTIGATED BY BD, IT WAS FOUND THAT THIS SOFTWARE ISSUE MAY HAVE LED TO FALSE NEGATIVE RESULTS DUE TO AN ERROR WITH THE IDENTIFICATION SOFTWARE FUNCTION IN THE INSTRUMENT. NO PATIENT IMPACT OR ADVERSE EVENT WAS REPORTED BY THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23289924 ↗MalfunctionOct 15, 2025Computer Operating System Problem; Computer Operating System Problem
IT WAS REPORTED THAT AFTER TESTING ON THE BD COR PX INSTRUMENT, A SOFTWARE ERROR OCCURRED WITH THE OVER-LABELING FUNCTION IN THE WORKFLOW. WHILE THIS ISSUE WAS BEING INVESTIGATED BY BD, IT WAS FOUND THAT THIS SOFTWARE ISSUE MAY HAVE LED TO FALSE NEGATIVE RESULTS DUE TO AN ERROR WITH THE IDENTIFICATION SOFTWARE FUNCTION IN THE INSTRUMENT. NO PATIENT IMPACT OR ADVERSE EVENT WAS REPORTED BY THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23289890 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under P160037. One submission often covers many models, so check the product and lot details in each record.
- Z-2162-2025 · Jun 23, 2025 · Open, ClassifiedBD COR System Software. Model Number: 444829.
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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