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BD BBL™ Crystal™ E/NF 245000Recalls & reported problems

Becton, Dickinson And Company · BD BBL™ Crystal™ E/NF · Class 1

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 30382902450000), received between Apr 13, 2021 and Apr 13, 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. How this data works · Data updated Oct 13, 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.

  • MalfunctionApr 13, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

    IT WAS REPORTED WHILE USING BD BBL¿ CRYSTAL¿ ENTERIC/NONFERMENTER ID SYSTEM KLEBSIELLA VARIICOLA WAS MISIDENTIFIED AS K PNEUMONIAE. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER REPORTS UNEXPECTED ID OF KLEBSIELLA VARIICOLA AS K PNEUMONIAE NO FURTHER FOLLOW UP NEEDED, CUSTOMER WAS ADVISED THAT K VARIICOLA IS NOT IN DATABASE TAXA LIST FOR IDENTIFICATION.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11659348 ↗

Other GRAM NEGATIVE IDENTIFICATION PANEL devices

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.