BD BBL™ Crystal™ GP Gram-Positive ID System 245240Recalls & reported problems

Becton, Dickinson And Company · BD BBL™ Crystal™ GP Gram-Positive ID System · Class 1

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports: 2
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 30382902452400), received between Mar 16, 2021 and Feb 15, 2022 — classified as 2 malfunctions.

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
Incorrect, Inadequate or Imprecise Result or Readings1

Patient problems

No Clinical Signs, Symptoms or Conditions2

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

MalfunctionFeb 15, 2022Device Markings/Labelling Problem; Device Markings/Labelling Problem
IT WAS REPORTED THAT THE BD BBL¿ CRYSTAL¿ GRAM-POSITIVE ID SYSTEM EXPERIENCED DISCREPANT LABEL INFORMATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: BATCH DIFFERENCE. THEY DELIVERED THIS MATERIAL WITH A CERTAIN BATCH, BUT WHEN THE CLIENT UNCOVERED THE BOX, THE MATERIAL INSIDE HAD ANOTHER BATCH THAT DID NOT APPEAR ON THE PAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13536918 ↗
MalfunctionMar 16, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED THAT WHILE USING BD BBL¿ CRYSTAL¿ GRAM-POSITIVE ID SYSTEM 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.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11490586 ↗

Device details

UDI-DI	`30382902452400`
Brand	BD BBL™ Crystal™ GP Gram-Positive ID System
Model	245240
Company	Becton, Dickinson And Company
Product code	LQL · GRAM POSITIVE IDENTIFICATION PANEL
Class	Class 1
FDA submission	None listed
Implant	No
Rx / OTC	Prescription
Single use	Yes
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	Not in Commercial Distribution
Record updated	Oct 23, 2024

Device type (GMDN): Multiple aerobic gram positive bacteria species culture isolate identification IVD, kit

A collection of reagents and other associated materials intended to be used for the differentiation and/or identification of one or multiple species of aerobic gram positive bacteria that have been isolated by culture from a clinical specimen. Bacteria which may be identified typically belong to the genera Staphylococcus, Enterococcus, or may represent other gram positive cocci and gram positive bacilli genera.

Other GRAM POSITIVE IDENTIFICATION PANEL devices

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MICROBACT LISTERIA 12L (20 ID'S) MB1128A
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1 recall0 reports

All GRAM POSITIVE IDENTIFICATION PANEL devices →

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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