Select 63747Recalls & reported problems
Bio-Rad · MRSASelect · Class 2
Data updated Oct 13, 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 03610520002933), received between Jun 15, 2018 and Jun 15, 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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- False Negative Result1
Patient problems
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 15, 2018False Negative Result
ON MAY 31, 2018, BIO-RAD LABORATORIES - (B)(4) OPERATIONS WAS MADE AWARE OF AN ISSUE WITH MRSASELECT AND (B)(6) SELECTII MEDIA PLATES. THESE PRODUCTS ARE SELECTIVE AND DIFFERENTIAL CHROMOGENIC MEDIA FOR THE QUALITATIVE DETECTION OF (B)(6) COLONIES. FOLLOWING REPORTS FROM THREE CUSTOMERS LOCATED OUTSIDE OF THE U.S., CONCERNING AN ABNORMAL COLORATION OF CERTAIN AGAR PLATES AND THE GROWTH OF NON-CHARACTERISTIC (B)(6) COLONIES, BIO-RAD LABORATORIES (INFECTIOUS DISEASE DIVISION, LOCATED IN (B)(4)) CONDUCTED AN INVESTIGATION AND CONFIRMED THAT CERTAIN LOTS MAY BE AT RISK FOR THIS ISSUE. TO DATE, BIO-RAD LABORATORIES INFECTIOUS DISEASE DIVISION HAS IDENTIFIED THE FOLLOWING KEY FEATURES OF THIS PRODUCT ISSUE: THE ORIGIN OF THE PROBLEM IS ISOLATED TO CERTAIN RAW MATERIALS. THE OBSERVATION OF A NON-CHARACTERISTIC COLORATION OF AGAR AND NON-CHARACTERISTIC (B)(6). COLONIES (COLONIES WITHOUT ANY PINK COLOR DEVELOPMENT) OCCURS WHEN THE MEDIA PLATES HAVE BEEN EXPOSED TO LIGHT FOR PROLONGED PERIODS DURING USE AND STORAGE. FOR MRSASELECT, THE ISSUE PRESENTS AFTER EXPOSURE PERIODS GREATER THAN 2 HOURS. FOR MRSASELECT II, THE ISSUE PRESENTS AFTER EXPOSURE PERIODS GREATER THAN 4 HOURS. MEDIA PLATES WI
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7607905 ↗
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
- CHROMID® MRSA / CHROMID S. aureusBiomerieux SA · Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar1 recall1 report
- 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
- CHROMID® VRE Agar chromID™ VRE AgarBiomerieux SA · 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
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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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