API® 50 CHL MediumRecalls & reported problems
Biomerieux SA · API 50 CHL Medium, for ID of Lactobacillus and related genera, is a ready-to-use allowing fermentation of the 49 carbohydrates on the API 50 CH strip (Ref. 50 300). · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 03573026588717), received between Oct 11, 2023 and Oct 11, 2023 — classified as 1 injury.
The most frequently reported specific device problem is “Leak/Splash” (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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Appropriate Device Problem Term/Code Not Available1
- Leak/Splash1
Patient problems
- Conjunctivitis1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryOct 11, 2023Leak/Splash; Appropriate Device Problem Term/Code Not Available; Leak/Splash; Appropriate Device Problem Term/Code Not Available
INTENDED USE: API® 50 CHL MEDIUM, INTENDED FOR THE IDENTIFICATION OF THE GENUS LACTOBACILLUS AND RELATED GENERA, IS A READY-TO-USE MEDIUM WHICH ALLOWS THE STUDY OF THE FERMENTATION OF THE 49 CARBOHYDRATES ON THE API® 50 CH STRIP. PRINCIPLE OF USE: A SUSPENSION IS PREPARED IN THE MEDIUM WITH THE MICROORGANISM TO BE TESTED AND EACH TUBE OF THE STRIP IS THEN INOCULATED WITH THE SUSPENSION. DURING INCUBATION, THE CARBOHYDRATES ARE FERMENTED TO ACIDS WHICH PRODUCE A DECREASE IN THE PH,DETECTED BY THE CHANGE IN COLOR OF THE INDICATOR. THE RESULTS MAKE UP THE BIOCHEMICAL PROFILE WHICH IS USED BY THE IDENTIFICATION SOFTWARE TO IDENTIFY THE STRAIN. DESCRIPTION OF THE ISSUE: A CUSTOMER IN JAPAN NOTIFIED BIOMÉRIEUX OF AN OPERATOR INJURY CAUSED BY THE API 50 CHL MEDIUM 10X10ML - REFERENCE 50410 (LOT NOT SPECIFIED) WHEN MANIPULATING THE PRODUCT. INDEED, THE CUSTOMER INDICATES THEY WERE USING A PIPETTE TO INJECT THE API 50 CHL MEDIUM INTO THE API50CH KIT WHEN THE TIP OF THE PIPETTE HIT THE KIT AND BOUNCED, CAUSING THE MEDIUM TO SPLASH INTO THEIR EYES. THE CUSTOMER WAS NOT WEARING GOGGLES AND DID NOT WASH THEIR EYES IMMEDIATELY. THE NEXT DAY, THE CUSTOMER WENT TO AN OPHTHALMOLOGIST BECAUSE THEY D
Patient problems: Conjunctivitis
MAUDE report 17910898 ↗
Other CULTURE MEDIA, GENERAL NUTRIENT BROTH devices
- API® 50 CHBiomerieux SA · CULTURE MEDIA, GENERAL NUTRIENT BROTH1 recall1 report
- Sensititre Supplemental Brucella Broth T3450Remel, Inc. · Culture Media, General Nutrient Broth1 recall0 reports
- BD BBL™ Brain Heart Infusion 220837Becton, Dickinson And Company · CULTURE MEDIA, GENERAL NUTRIENT BROTH14 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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