NA R01186Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00848838000546), received between Apr 15, 2021 and Apr 15, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Defective Device” (1 report).

1 other recall cover devices cleared under the same FDA submission (K972359); they may or may not involve this specific model.

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

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 15, 2021Defective Device; Defective Device

  CUSTOMER REPORTS BREAKTHROUGH GROWTH OF NEGATIVE QC STRAIN E. FAECALIS 29212 DURING QC TESTING. CUSTOMER STATES IT'S GROWING BETTER THAN THE POSITIVE STRAIN E. FAECALIS ATCC 51299 AND HAS THE BLACKENING. LOT NUMBER 237214 WAS SET UP SIDE BY SIDE WITH SAME BUG AND PERFORMED AS EXPECTED. LATER, THE CUSTOMER REPORTED THEY USED NEW CULTILOOP OF E.FAECALIS 29212 (LOT #929106 EXP 7/29/21). CUSTOMER PERFORMED RETEST QC USING 0.5 MCFARLAND OF THE QC ORGANISM ALONG WITH A 1:10 AND 1:100 DILUTION OF THE 0.5 MCFARLAND. ALL THREE FAILED QC. THE NEW LOT OF BILE ESCULIN AZIDE #255981 PASSED QC. NO PATIENT IMPACT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11674661 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K972359. One submission often covers many models, so check the product and lot details in each record.

• Z-1561-2021 · Apr 22, 2021 · Terminated
  Remel Bile Esculin Azide Agar w/ 6mcg/ml Vancomycin, Product #R01186, 10/package - Product Usage: use in qualitative procedures as a screening method for primary isolation and pre