API® Staph 20500Recalls & reported problems
Biomerieux SA · API® Staph is a standardized system for the identification of the genera Staphylococcus, Micrococcus and Kocuria · Class 1
Data updated Oct 16, 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 03573026048259), received between Apr 30, 2021 and Apr 30, 2021 — classified as 1 malfunction.
The most frequently reported specific device problem is “Inaccurate Information” (1 report).
1 FDA recall record name this device's identifier, 1 still open.
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.
Recalls naming this device
- Nov 9, 2022Open, Classified
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
Z-0786-2023 · Root cause: Storage · Recall details · FDA record ↗
Most reported problems
Device problems
- Inaccurate Information1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 30, 2021Inaccurate Information; Inaccurate Information
A CUSTOMER FROM (B)(6) REPORTED HE OBSERVED A DISCREPANCY BETWEEN THE INSTRUCTIONS FOR USE (IFU) VERSION M AND N FOR THE ADH TEST OF QUALITY CONTROL STRAIN S.CAPITIS FOR THE PRODUCT API® STAPH 25STRIPS+25MEDIA (REF. 20500). WHEN PERFORMING QUALITY ASSURANCE TESTING, THE CUSTOMER GOT A POSITIVE RESULT FOR ADH TEST USING STAPHYLOCOCCUS CAPITIS ATCC® 35661¿, AND THEIR RESULT FOR ADH TEST DID NOT CONFORM WITH THE PROFILE INCLUDED IN THE PACKAGE INSERT 07468 VERSION N. THE VERSION ¿07468 M - EN - 2017/03¿ HAS THE EXPECTED ADH TEST RESULT IN THE PROFILE FOR STAPHYLOCOCCUS CAPITIS LISTED AS POSITIVE WHILE THE NEWEST VERSION ¿07468 - N - 2019/05 ¿ EN¿ HAS THE EXPECTED ADH TEST RESULT IN THE PROFILE FOR STAPHYLOCOCCUS CAPITIS LISTED AS NEGATIVE. THE ADH TEST RESULT IN THE PROFILE FOR STAPHYLOCOCCUS CAPITIS WAS MODIFIED BY MISTAKE IN THE VERSION N OF THE IFU. THE CUSTOMER REPORTED THEY PERFORM QUALITY CONTROL WITH S.CAPITIS ATCC® 35661¿ ON EVERY LOT RECEIVED AND ALWAYS OBSERVED A POSITIVE RESULT FOR THE ADH TEST WITH S.CAPITIS STRAIN. THE CUSTOMER ALSO TESTS STAPHYLOCOCCUS XYLOSUS ATCC® 700404¿ AND STAPHYLOCOCCUS LENTUS ATCC® 700403¿ WHEN RECEIVING A NEW LOT. THE INFORMATION FOR THESE STRAIN
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11755693 ↗
Other KIT, SCREENING, STAPHYLOCOCCUS AUREUS devices
- ID 32 STAPHBiomerieux SA · KIT, SCREENING, STAPHYLOCOCCUS AUREUS1 report
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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