Bromelin for Erytype 806210100 (UDI 07611969951307)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07611969951307), received between Jan 16, 2017 and Jan 16, 2017 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device Reprocessing Problem” (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 18, 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.

• MalfunctionJan 16, 2017Device Reprocessing Problem; False Negative Result

  THE CUSTOMER REPORTED A MISTYPING OF TWO DONOR SAMPLES AND ONE PATIENT SAMPLE ON TANGO OPTIMO. THE TWO DONOR UNITS WERE LABELLED AS A POS, BUT TANGO OPTIMO CALLED ONE SAMPLE O NEG AND THE SECOND ONE A NEG. THE PATIENT SAMPLE WAS B POS, BUT THE INSTRUMENT TYPED IT AS B NEG. THE CUSTOMER SUSPECTED THE BROMELIN TO BE THE CAUSE FOR THE FALSE NEGATIVE RESULTS. THE CUSTOMER ASSUMED THAT THE BROMELIN SOLUTION WAS FILLED IN BOTTLES THAT MIGHT NOT HAVE BEEN CLEANED AS THOROUGHLY AS USUAL. THE CUSTOMER REPORTED THAT THE ISSUE WAS RESOLVED AFTER SHE HAD CLEANED THE BROMELIN BOTTLES AND MADE FRESH BROMELIN SOLUTIONS. THE CUSTOMER RETURNED THE SUPPOSEDLY DEFECTIVE PRODUCT, BUT NOT THE DONOR RESPECTIVELY PATIENT SAMPLES WHICH HAD CAUSED FALSE NEGATIVE TEST RESULTS. OUR QUALITY CONTROL LABORATORY PREPARED THE READY TO USE SOLUTION OF THE PROVIDED BROMELIN AND TESTED IT ON TANGO OPTIMO. DIFFERENT DONOR SAMPLES WERE TESTED ON THE ERYTYPE CONFIGURATIONS ERYTYPE S ABD+REV.A1, B, ERYTYPE RHD CONFIRM, ERYTYPE S ABO CONFIRM AND ERYTYPE S RH+K TYPE. ALL POSITIVE AND NEGATIVE REACTIONS WERE CORRECT. WE DID NOT OBSERVE ANY FALSE NEGATIVE REACTIONS. TESTING BY OUR QUALITY CONTROL LABORATORY CONFIRMED THAT T

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6252955 ↗