CHROMID® MRSA / CHROMID S. aureusRecalls & reported problems
Biomerieux SA · Chromogenic medium for the screening and qualitative detection of methicillin-resistant Staphylococcus aureus and selective isolation of staphylococci and the direct identification of S. aureus. · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 03573026552091), received between Feb 26, 2021 and Feb 26, 2021 — classified as 1 malfunction.
The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (1 report).
1 FDA recall record name this device's identifier, 1 still open.
1 other recall cover devices cleared under the same FDA submission (K151688, K162076); they may or may not involve this specific model.
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.
Recalls naming this device
- Nov 9, 2022Class IIOpen, Classified
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
Z-0842-2023 · Root cause: Storage · Recall details · FDA record ↗
Most reported problems
Device problems
- Incorrect, Inadequate or Imprecise Result or Readings1
Patient problems
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 26, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
A CUSTOMER IN THE UNITED STATES REPORTED A FALSE NEGATIVE RESULT ON CHROMID® (B)(6). NO GREEN PIGMENTATION OF AN (B)(6) STRAIN WAS OBSERVED FROM A CAP SURVEY ON THE CHROMID (B)(6) 20 PLATE, REFERENCE 414524. THE IMPACTED LOT NUMBER WAS NOT PROVIDED. THE CUSTOMER REPORTED THAT NO PATIENT WAS IMPACTED AS THE PLATE WAS USED FOR A CAP SURVEY. QUALITY CONTROL TESTING HAS BEEN PERFORMED BY THE CUSTOMER; THE RESULTS WERE IN CONFORMANCE WITH SPECIFICATIONS. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 11386901 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K151688, K162076. One submission often covers many models, so check the product and lot details in each record.
- Z-0802-2023 · Nov 9, 2022 · Open, ClassifiedPPM CLINICAL CHROMID MRSA 20 PLT US, CATALOG 43841
Other Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar devices
- BD BBL™ CHROMagar® MRSA II 215229Becton, Dickinson And Company · CULTURE MEDIA, ANTIMICROBIAL SUSCEPTIBILITY TEST, EXCLUDING MUELLER HINTON AGAR122 reports
- CHROMID® MRSA agarBiomerieux SA · Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar1 recall2 reports
- NA R04033Remel, Inc. · Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar1 recall0 reports
- NA G14Hardy Diagnostics · Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar1 recall0 reports
- NA R01503Remel, Inc. · Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar1 recall0 reports
- CHROMID® VRE Agar chromID™ VRE AgarBiomerieux SA · Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar1 recall0 reports
- CHROMID® CARBA agarBiomerieux SA · CULTURE MEDIA, ANTIMICROBIAL SUSCEPTIBILITY TEST, EXCLUDING MUELLER HINTON AGAR1 recall0 reports
- HardyCHROM™ G307Hardy Diagnostics · Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar1 recall0 reports
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 · each recall links to the FDA recall notice
- 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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