IH-Card Group ABO 813170100Recalls & reported problems
Bio-Rad Medical Diagnostics GmbH · Gel card for use with the IH-system; Card for ABO antigen typing; 12 cards of 6 microtubes
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 07611969962358), received between May 27, 2020 and May 27, 2020 — 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 Clinical Signs, Symptoms or Conditions1
- 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.
MalfunctionMay 27, 2020False Positive Result
THE CUSTOMER REPORTED FALSE POSITIVE RESULTS WITH ANTI-A AND ANTI-B OF IH-CARD GROUP ABO ON THE IH-READER 24. THE CUSTOMER NOTICED VARYING GEL LEVELS ON SOME OF THE IH-CARDS. THE CUSTOMER DID NEITHER RETURN THE SUPPOSEDLY DEFECTIVE PRODUCT FOR INVESTIGATIONAL TESTING NOR THE SAMPLES THAT HAD CAUSED FALSE POSITIVE TEST RESULTS. BUT HE PROVIDED IMAGES WHICH SHOWED THE FALSE POSITIVES. OUR QUALITY CONTROL LABORATORY TESTED THEIR RETENTION SAMPLE WITH DIFFERENT CONTROLS AND DONOR SAMPLES ON THE IH-READER 24. ALL POSITIVE AND NEGATIVE RESULTS WERE CORRECT. WE DID NOT OBSERVE ANY FALSE POSITIVE REACTION. THE INVESTIGATION AT THE CUSTOMER´S SITE IS STILL ONGOING. A REVIEW OF THE BATCH RECORD DOCUMENTATION SHOWED NO IRREGULARITIES WHICH MIGHT HAVE NEGATIVELY AFFECTED THE QUALITY OF THE ALLEGEDLY DEFECTIVE LOT.
Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient
MAUDE report 10091534 ↗
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.
How reports and recalls are matched · Editorial policy · Report an error on this page