CHROMID® P. aeruginosa AgarRecalls & reported problems
Biomerieux SA · Direct identification of Pseudomonas aeruginosa in pulmonary specimens. · 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 03573026599416), received between Jun 20, 2018 and Jun 20, 2018 — classified as 1 malfunction.
The most frequently reported specific device problem is “False Negative Result” (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
- False Negative Result1
Patient problems
- No Patient Involvement1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 20, 2018False Negative Result; False Negative Result
A CUSTOMER IN THE (B)(6) CONTACTED BIOMÉRIEUX TO REPORT NO GROWTH FOR A NEQAS SPECIMEN (P. AERUGINOSA 10) IN ASSOCIATION WITH THE CHROMID® PSEUDOMONAS AERUGINOSA AGAR PLATE. THE SAME STRAIN GREW OF CPSE PLATES. THE CUSTOMER STATED THE INOCULATED PLATES WERE INCUBATED FOR 48 HOURS (READ AT 24 HOURS, THEN RE-INCUBATED FOR A FURTHER 24 HOURS). THE CUSTOMER DOES NOT KNOW THE LOT NUMBER OF THE PLATES. IN ADDITION, THE NEQAS STRAIN WAS NOT RETAINED BY THE CUSTOMER; THEREFORE NO INVESTIGATION SUBMITTAL IS POSSIBLE. THE CUSTOMER INDICATED "THIS NEQAS STRAIN WAS NOT SCORED AS 23% OF LABS REPORTED A FALSE NEGATIVE RESULT; THIS PARTICULAR STRAIN HAD UNUSUAL GROWTH REQUIREMENTS". THE CUSTOMER REVIEWED THE PACKAGE INSERT FOR THE CHROMID PSEUDOMONAS AERUGINOSA AGAR, AND IT STATES "GROWTH DEPENDS ON THE REQUIREMENTS OF EACH INDIVIDUAL MICRO-ORGANISM. IT IS THEREFORE POSSIBLE THAT CERTAIN STRAINS OF PSEUDOMONAS AERUGINOSA WHICH HAVE SPECIFIC REQUIREMENTS (SUBSTRATE, TEMPERATURE, INCUBATION ATMOSPHERE) MAY NOT DEVELOP OR MAY NOT PRODUCE TYPICAL COLONIES." THERE IS NO INDICATION OR REPORT FROM THE LABORATORY TO BIOMÉRIEUX THAT THE FALSE NEGATIVE RESULT LED TO ANY ADVERSE EVENT RELATED TO ANY PATIENT
Patient problems: No Patient Involvement
MAUDE report 7618707 ↗
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- BD BBL™ CHROMagar™ Candida 254093Becton, Dickinson And Company · CULTURE MEDIA, SELECTIVE AND DIFFERENTIAL29 reports
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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
- 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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