Erytype S Rh+K Type 806195100Recalls & reported problems
Bio-Rad Medical Diagnostics GmbH · Microplate for Rh and K typing with the TANGO instruments; 10 Plates
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07611969951291), received between Apr 24, 2018 and Apr 24, 2018 — classified as 1 malfunction.
The most frequently reported specific device problem is “False Positive Result” (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
Device problems
- False Positive Result1
Patient problems
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 24, 2018False Positive Result
THE CUSTOMER REPORTED THAT A PATIENT SAMPLE SHOWED A FALSE POSITIVE ANTIBODY SCREENING REACTION WHEN TESTED WITH ERYTYPE S RH+K TYPE ON TANGO INFINITY WHEREAS A SAMPLE OF THE PATIENT TESTED WITH ERYTYPE S RH+ K-TYPE ON MARCH, 09 YIELDED NEGATIVE TEST RESULTS. BECAUSE OF THE POSITIVE TEST RESULTS ON ERYTYPE S THE CUSTOMER TYPED THE PATIENT SAMPLE FOR E AND C ANTIGEN BY USING THE TUBE TECHNIQUE AND YIELDED NEGATIVE TEST RESULTS. DUE TO THE CURRENT POSITIVE ANTIBODY SCREENING TEST THE CUSTOMER ASSUMED THAT THE PATIENT HAS BEEN TRANSFUSED. THE CUSTOMER DID RETURN THE PATIENT SAMPLE THAT HAD CAUSED A FALSE POSITIVE REACTION AN DID RETURN THE SUPPOSEDLY DEFECTIVE PRODUCT FOR INVESTIGATIONAL TESTING. WHEN OUR QUALITY CONTROL RECEIVED THE COMPLAINT SAMPLE THE SHELF LIFE OF THE SUPPOSEDLY DEFECTIVE PRODUCT WAS ALREADY EXPIRED. NEVERTHELESS OUR QUALITY CONTROL LABORATORY TESTED THE PATIENT SAMPLE WITH THE COMPLAINT PRODUCT OF ERYTYPE RH+K TYPE ON TANGO INFINITY. THE PATIENT SAMPLE YIELDED A WEAK POSITIVE REACTION WITH ANTI-C ON ERYTYPE S RH+K TYPE. THE PATIENT SAMPLE WAS ALSO TESTED WITH OUR RETENTION SAMPLE AND THE CURRENT LOT OF ERYTYPE S RH+K TYPE. THE PATIENT SAMPLE SHOWED A WEAK POSITIV
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7453912 ↗
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
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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