BD PhoenixSpec™ Calibrator Kit 440911Recalls & reported problems
Becton, Dickinson And Company · BD PhoenixSpec™ Calibrator Kit · Class 1
Data updated Oct 16, 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 00382904409111), received between Jun 8, 2021 and Jun 8, 2021 — classified as 1 malfunction.
The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (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 16, 2026.
Most reported problems
Device problems
- Incorrect, Inadequate or Imprecise Result or Readings1
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.
MalfunctionJun 8, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED THAT WHILE USING BD PHOENIXSPEC¿ CALIBRATOR KIT ATYPICAL GROWTH WAS OBSERVED BY THE LABORATORY PERSONNEL. THERE WAS NO INDICATION THAT RESULTS WERE REPORTED OUT AND THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "EVIDENCE OF READING OUT OF RANGE OF NEW PHOENIX SPEC CALIBRATION KIT 0.25 MF STANDARD TUBE. SHOWS HIGHER THAN NORMAL READING (0.29 MF). LOT 1004886 F, EXPIRATION: 2021-11-06."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11959044 ↗
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™ AP Calibrator Kit 441951Becton, 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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