Select 63758Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 03610521536208), received between Jun 15, 2018 and Jun 15, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Incorrect Or Inadequate Test Results” (1 report).

1 other recall cover devices cleared under the same FDA submission (K171061); 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.

• MalfunctionJun 15, 2018Material Discolored; Incorrect Or Inadequate Test Results

  ON (B)(6) 2018, (B)(6) LABORATORIES - (B)(4) OPERATIONS WAS MADE AWARE OF AN ISSUE WITH (B)(6) SELECT AND (B)(6) SELECTII MEDIA PLATES. THESE PRODUCTS ARE SELECTIVE AND DIFFERENTIAL CHROMOGENIC MEDIA FOR THE QUALITATIVE DETECTION OF (B)(6) COLONIES. FOLLOWING REPORTS FROM THREE CUSTOMERS LOCATED OUTSIDE OF THE U.S., CONCERNING AN ABNORMAL COLORATION OF CERTAIN AGAR PLATES AND THE GROWTH OF NON-CHARACTERISTIC (B)(6) COLONIES, BIO-RAD LABORATORIES (INFECTIOUS DISEASE DIVISION, LOCATED IN (B)(4)) CONDUCTED AN INVESTIGATION AND CONFIRMED THAT CERTAIN LOTS MAY BE AT RISK FOR THIS ISSUE. TO DATE, (B)(6) LABORATORIES INFECTIOUS DISEASE DIVISION HAS IDENTIFIED THE FOLLOWING KEY FEATURES OF THIS PRODUCT ISSUE: THE ORIGIN OF THE PROBLEM IS ISOLATED TO CERTAIN RAW MATERIALS. THE OBSERVATION OF A NON-CHARACTERISTIC COLORATION OF AGAR AND NON-CHARACTERISTIC (B)(6) COLONIES (COLONIES WITHOUT ANY PINK COLOR DEVELOPMENT) OCCURS WHEN THE MEDIA PLATES HAVE BEEN EXPOSED TO LIGHT FOR PROLONGED PERIODS DURING USE AND STORAGE. FOR (B)(6) SELECT, THE ISSUE PRESENTS AFTER EXPOSURE PERIODS GREATER THAN 2 HOURS. FOR (B)(6) SELECT II, THE ISSUE PRESENTS AFTER EXPOSURE PERIODS GREATER THAN 4 HOURS. MEDIA PLAT

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7607927 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K171061. One submission often covers many models, so check the product and lot details in each record.

• Z-1743-2019 · Jun 8, 2018 · Terminated
  MRSASelect II, IVD, REF 63758 (20 plates per package). The MRSASelect is indicated for use in conjunction with other laboratory tests and clinical data available to aid in the id