IH-Cell Pool 814060100Recalls & reported problems
Bio-Rad Medical Diagnostics GmbH · Reagent Red Blood Cells; 0.6 ± 0.1 %; Pooled cells for use in detection of unexpected antibodies with IH-Cards; 1 x 10 mL
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 07611969952281), received between Nov 15, 2021 and Nov 15, 2021 — classified as 1 malfunction.
The most frequently reported specific device problem is “False Negative 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 Negative Result1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 15, 2021False Negative Result; False Negative Result
THE CUSTOMER REPORTED THAT ONE RESULT WAS CALLED NEGATIVE BY THE IH-1000 SN (B)(4) WHEN USING IH-CELL POOL, ALTHOUGH IT LOOKED VISUALLY LIKE A +/- REACTION. THE CUSTOMER STATED THAT THE PELLET LOOKED UNEVEN. THE SAMPLE WAS ALSO TESTED ON THE IH-1000 SN (B)(4) AND YIELDED A 1+ POSITIVE REACTION. THE CUSTOMER DID NOT PROVIDE THE COMPLAINT SAMPLE FOR INVESTIGATIONAL TESTING BUT ANNOUNCED TO SHIP THE AFFECTED PATIENT SAMPLE. OUR QUALITY CONTROL LABORATORY IS STILL WAITING FOR THE PATIENT SAMPLE. IN THE MEANTIME, OUR QUALITY CONTROL LABORATORY TEAM TESTED THEIR RETENTION SAMPLE OF THE SUPPOSEDLY DEFECTIVE LOT IH-CELL POOL ON IH-1000. THE TESTING WAS PERFORMED WITH SEVERAL WEAK REACTION ANTIBODIES AND CONTROLS. ALL POSITIVE AND NEGATIVE REACTIONS WERE CORRECT. THEY WERE CORRECTLY EVALUATED. WE DID NOT OBSERVE ANY FALSE NEGATIVE REACTION. A REVIEW OF THE BATCH RECORD DOCUMENTATION SHOWED NO IRREGULARITIES WHICH MIGHT HAVE NEGATIVELY AFFECTED THE QUALITY OF THE ALLEGEDLY DEFECTIVE LOT. THE INVESTIGATION OF THE AFFECTED IH-1000 INSTRUMENT IS STILL ONGOING
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12810994 ↗
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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