Panocell-16 0002332Recalls & reported problems
Immucor, Inc. · This product is used in the identification of unexpected red cell blood group antibodies. This product is manufactured as 16 vials of reagent in a set. Reagent red blood cell vials each contain a 2-4% suspension of group O red blood cells prepared in a buffered preservative solution.
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10888234000242), received between Aug 22, 2017 and Oct 17, 2017 — classified as 2 malfunctions.
The most frequently reported specific device problem is “False Negative 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- False Negative Result2
Patient problems
- No Consequences Or Impact To Patient2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 17, 2017False Negative Result
ON (B)(6) 2017, A CUSTOMER SITE IN (B)(6) REPORTED AN UNEXPECTED (B)(6) ANTIBODY IDENTIFICATION TEST, WHEN TESTED ON (B)(6) 2017.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6955060 ↗MalfunctionAug 22, 2017False Negative Result
ON (B)(6)2017, A CUSTOMER SITE REPORTED AN UNEXPECTED NEGATIVE ANTIBODY IDENTIFICATION TEST.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6811983 ↗
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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