Bromelin for Erytype 806210100 (UDI 07611969965755)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07611969965755), received between Jul 27, 2017 and Aug 11, 2017 — classified as 2 malfunctions.

The most frequently reported specific device problem is “False Positive Result” (2 reports).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 11, 2017False Positive Result

  THE CUSTOMER REPORTED A FALSE POSITIVE RESULTS FOR ANTI-D ON TWO DIFFERENT TANGO OPTIMO ON SITE WHEN USING BROMELIN FOR ERYTYPE. THE CUSTOMER SUSPECTED THAT THE BROMELIN FOR ERYTYPE WOULD NOT WORK FOR FULL 24 HOURS AFTER PREPARING THE WORKING SOLUTION. THE CUSTOMER OBSERVED "WEIRD LOOKING RESULTS" IN THE D- WELLS WHEN USING SOLUTION THAT WAS PREPARED APPROXIMATELY 22 HOURS AGO. THE CUSTOMER DID NOT SEND IN THE ALLEGEDLY DEFECTIVE FOR INVESTIGATIONAL TESTING. THEREFORE OUR QUALITY CONTROL LABORATORY TESTED THEIR RETAINED SAMPLE OF THE SUPPOSEDLY DEFECTIVE LOT BROMELIN FOR ERYTYPE AND ALSO A REFERENCE LOT. BOTH REAGENTS WERE TESTED WHEN FRESHLY PREPARED AND A SECOND TIME AFTER 22 HOURS "ON BOARD". ERYTYPE S ABD+REV.A1B #8646110 WAS USED FOR THE TESTING WHICH IS THE SAME LOT THAT WAS USED BY THE CUSTOMER. ALL POSITIVE AND NEGATIVE REACTIONS WERE CORRECT. WE DID NOT OBSERVE ANY FALSE POSITIVE REACTION. A REVIEW OF THE BATCH RECORD DOCUMENTATION SHOWED NO IRREGULARITIES WHICH MIGHT HAVE NEGATIVE INFLUENCES ON THE QUALITY OF THE ALLEGEDLY DEFECTIVE LOT BROMELIN FOR ERYTYPE. BOTH AFFECTED TANGO OPTIMO WERE CHECKED BY OUR FIELD SERVICE ENGINEER. NO INDICATION FOR AN INSTRUMENT MALFUNCTION

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6787396 ↗
• MalfunctionJul 27, 2017False Positive Result

  THE CUSTOMER REPORTED A DISCREPANCY WHEN TYPING ON TWO TANGO OPTIMO INSTRUMENTS. RH NEGATIVE SAMPLES WERE BEING READ AS POSITIVE. THE CUSTOMER SUSPECTED THE BROMELIN FOR ERYTYPE TO BE THE CAUSE FOR THE FALSE POSITIVE RESULTS. THE CUSTOMER SENT BACK THE ALLEGEDLY DEFECTIVE PRODUCT BROMELIN FOR ERYTYPE FOR INVESTIGATIONAL TESTING BUT AT THE TIME THE ALLEGEDLY DEFECTIVE PRODUCT ARRIVED AT BMD IT WAS ALREADY EXPIRED, WAS CONTAMINATED AND EVEN MOULDY. THEREFORE OUR QUALITY CONTROL LABORATOY TESTED THEIR RETAINED SAMPLE BROMELIN FOR ERYTYPE, #8701110-00. THE ERYTYPE S ABD+REV. A1B #8646110, THAT WAS USED BY THE CUSTOMER, WAS ALSO USED IN THIS TEST. 12 SAMPLES WERE TESTED AND ALL REACTIONS WERE AS EXPECTED. WE DID NOT OBSERVE ANY FALSE POSITIVE REACTION. A REVIEW OF THE BATCH RECORD DOCUMENTATION SHOWED NO IRREGULARITIES WHICH MIGHT HAVE NEGATIVE INFLUENCES ON THE QUALITY OF THE ALLEGEDLY DEFECTIVE LOT OF BROMELIN FOR ERYTYPE. BOTH AFFECTED TANGO OPTIMO WERE INSPECTED BY OUR FIELD SERVICE ENGINEER WITH NO INDICATION FOR A MALFUNCTION. BOTH INSTRUMENTS ARE WORKING WITHIN SPECIFICATIONS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6747023 ↗