ZYM B 70493Recalls & reported problems
Biomerieux SA · ZYM B is a reagent associated to API® Listeria (10 300), API® NH (10 400), API® Staph (20 500), API® 20 Strep (20 600), API® Coryne (20 900), API® ZYM (25 200) · Class 1
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 03573026141998), received between Dec 23, 2020 and Dec 23, 2020 — classified as 1 malfunction.
The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (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
- Incorrect, Inadequate or Imprecise Result or Readings1
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.
MalfunctionDec 23, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
A CUSTOMER IN (B)(6) NOTIFIED BIOMÉRIEUX OF A QUALITY CONTROL FAILURE WHEN TESTING A LISTERIA INNOCUA ATCC 33090 STRAIN ASSOCIATED WITH API® LISTERIA 10STRIPS+10MEDIA ¿ (REF. 10300, LOT. # 1007942830)(COMPLAINT REPORTED SEPARATELY UNDER MEDWATCH 9615754-2020-00183) IN ASSOCIATION WITH THE SUPPLEMENTAL ZYM B X2 REAGENT¿ (REF. 70493, LOT. #1007922470) (PRESENT REPORT). THE PRESENT REPORT HAS BEEN CREATED FOLLOWING TROUBLESHOOTING INFORMATION, AGAINST THE ZYM B X2 REAGENT LOT THAT WAS TESTED IN ASSOCIATION WITH THE API LISTERIA STRIP. THE CUSTOMER NOTED THAT THEIR NORMAL PROCEDURE IS THAT WHEN THEY RUN OUT OF THE ZYM B X2 REAGENT THAT COMES WITH THE API STRIPS THAT THEY USE ZYM B X2 FROM THESE SUPPLEMENTAL PACKAGES (REF. 70493). THE CUSTOMER STATED THAT WHEN TESTING LISTERIA INNOCUA ATCC® 33090¿ STRAIN, THE QUALITY CONTROL FAILED FOR THE DIM WELL GIVING A NEGATIVE RESULT INSTEAD OF A POSITIVE RESULT, WHICH RESULTED IN A MISIDENTIFICATION OF THE QUALITY CONTROL STRAIN. THEY OBTAINED AN IDENTIFICATION WITH THE API SYSTEM AS L. MONOCYTOGENES SPECIES INSTEAD OF THE EXPECTED IDENTIFICATION OF LISTERIA INNOCUA. THE CUSTOMER TESTED THE API STRIPS WITH OTHER ATCC STRAINS FOR QUALITY CONTROL W
Patient problems: No Patient Involvement
MAUDE report 11068208 ↗
Other DISCS, STRIPS AND REAGENTS, MICROORGANISM DIFFERENTIATION devices
- API® LISTERIA 10300Biomerieux SA · DISCS, STRIPS AND REAGENTS, MICROORGANISM DIFFERENTIATION1 recall13 reports
- JAMES 70542Biomerieux SA · DISCS, STRIPS AND REAGENTS, MICROORGANISM DIFFERENTIATION1 recall0 reports
- NIT 1 + NIT 2 70442Biomerieux SA · DISCS, STRIPS AND REAGENTS, MICROORGANISM DIFFERENTIATION1 recall0 reports
- Chemmette Reagents 300145Microbiologics Inc. · Discs, strips and reagents, microorganism differentiation1 recall0 reports
- VP 1 + VP 2 70422Biomerieux SA · 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 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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