ID color CatalaseRecalls & reported problems
Biomerieux SA · Manual reagent for catalase test. API®strips give accurate identifications based on extensive databases and are standardized, easy-to-use test systems. · 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 03573026584139), received between Oct 14, 2020 and Oct 14, 2020 — classified as 2 malfunctions.
The most frequently reported specific device problem is “False Positive Result” (2 reports).
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 Positive Result2
Patient problems
- No Known Impact Or Consequence To Patient2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 14, 2020False Positive Result; False Positive Result
A CUSTOMER FROM GERMANY NOTIFIED BIOMÉRIEUX OF FALSE POSITIVE RESULTS IN ASSOCIATION WITH ID COLOR CATALASE (REF. 55561, LOT 1007568120). THE CUSTOMER TESTED ATCC® 29212¿ ENTEROCOCCUS FAECALIS AND AN UNKNOWN NUMBER OF PATIENT ENTEROCOCCUS FAECALIS AND STREPTOCOCCI STRAINS WITH LOT 1007568120. THE NUMBER OF PATIENT STRAINS IMPACTED WAS NOT PROVIDED. THE CUSTOMER STATED THE FALSE POSITIVE CATALASE RESULT CAUSED THE INCORRECT VITEK® 2 CARDS TO BE USED FOR ANTIBIOTIC SUSCEPTIBILITY TESTING (AST) LEADING TO A DELAY IN OBTAINING AST RESULTS. THE CUSTOMER ALSO TESTED THE ISOLATES USING LOT 1007205060; FALSE POSITIVE RESULTS WERE ALSO OBTAINED. THERE IS NO INDICATION OR REPORT FROM THE LABORATORY THAT THE FALSE POSITIVE RESULT LED TO ANY ADVERSE EVENT RELATED TO ANY PATIENT'S STATE OF HEALTH. BIOMÉRIEUX HAS INITIATED AN INTERNAL INVESTIGATION.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10678878 ↗MalfunctionOct 14, 2020False Positive Result; False Positive Result
A CUSTOMER FROM (B)(6) NOTIFIED BIOMÉRIEUX OF FALSE POSITIVE RESULTS IN ASSOCIATION WITH ID COLOR CATALASE (REF. 55561, LOT: 1007205060). THE CUSTOMER TESTED ATCC® 29212¿ ENTEROCOCCUS FAECALIS AND AN UNKNOWN NUMBER OF PATIENT ENTEROCOCCUS FAECALIS AND STREPTOCOCCI STRAINS WITH LOT:1007205060. THE NUMBER OF PATIENT STRAINS IMPACTED WAS NOT PROVIDED. THE CUSTOMER STATED THE FALSE POSITIVE CATALASE RESULT CAUSED THE INCORRECT VITEK® 2 CARDS TO BE USED FOR ANTIBIOTIC SUSCEPTIBILITY TESTING (AST) LEADING TO A DELAY IN OBTAINING AST RESULTS. THE CUSTOMER ALSO TESTED THE ISOLATES USING LOT 1007568120; FALSE POSITIVE RESULTS WERE ALSO OBTAINED. THERE IS NO INDICATION OR REPORT FROM THE LABORATORY THAT THE FALSE POSITIVE RESULT LED TO ANY ADVERSE EVENT RELATED TO ANY PATIENT'S STATE OF HEALTH. BIOMÉRIEUX HAS INITIATED AN INTERNAL INVESTIGATION.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10678758 ↗
Other DISCS, STRIPS AND REAGENTS, MICROORGANISM DIFFERENTIATION devices
- API® LISTERIA 10300Biomerieux SA · DISCS, STRIPS AND REAGENTS, MICROORGANISM DIFFERENTIATION1 recall13 reports
- NIT 1 + NIT 2 70442Biomerieux SA · DISCS, STRIPS AND REAGENTS, MICROORGANISM DIFFERENTIATION1 recall0 reports
- JAMES 70542Biomerieux SA · DISCS, STRIPS AND REAGENTS, MICROORGANISM DIFFERENTIATION1 recall0 reports
- VP 1 + VP 2 70422Biomerieux SA · DISCS, STRIPS AND REAGENTS, MICROORGANISM DIFFERENTIATION1 recall0 reports
- Chemmette Reagents 300145Microbiologics Inc. · Discs, strips and reagents, microorganism differentiation1 recall0 reports
- RAPID ID 32 STREPBiomerieux SA · DISCS, STRIPS AND REAGENTS, MICROORGANISM DIFFERENTIATION5 reports
- API® 20 STREP 20600Biomerieux SA · DISCS, STRIPS AND REAGENTS, MICROORGANISM DIFFERENTIATION4 reports
- BD BBL™ DMACA Indole Reagent Droppers 261187Becton, Dickinson And Company · DISCS, STRIPS AND REAGENTS, MICROORGANISM DIFFERENTIATION4 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
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page