BD PhoenixSpec™ AP Calibrator Kit 441951Recalls & reported problems
Becton, Dickinson And Company · BD PhoenixSpec™ AP Calibrator Kit · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00382904419516), received between Oct 27, 2021 and Oct 27, 2021 — classified as 1 malfunction.
The most frequently reported specific device problem is “Device Markings/Labelling Problem” (1 report).
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.
Most reported problems
Device problems
- Device Markings/Labelling Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 27, 2021Device Markings/Labelling Problem; Device Markings/Labelling Problem
IT WAS REPORTED THAT WHILE USING BD PHOENIXSPEC¿ AP CALIBRATOR KIT AN INCORRECT EXPIRATION DATE WAS OBSERVED BY THE LABORATORY PERSONNEL. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CLIENT HAS RECEIVED A NEW CALIBRATOR WITH EXPIRY DATE : 15APR2020"
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12704406 ↗
Other NEPHELOMETER, FOR CLINICAL USE devices
- BD Phoenix™ AP 448010Becton, Dickinson And Company · NEPHELOMETER, FOR CLINICAL USE150 reports
- IMMAGE A15445Beckman Coulter, Inc. · Nephelometer, For Clinical Use4 reports
- BD PhoenixSpec™ Calibrator Kit 440911Becton, Dickinson And Company · NEPHELOMETER, FOR CLINICAL USE1 report
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
- 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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