Panocell-20 0005020Recalls & reported problems
Immucor, Inc. · This product is used in the identification of unexpected red cell blood group antibodies. This product is manufactured as twenty (20) 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 10888234001843), received between Jun 1, 2018 and Jan 4, 2021 — 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 Clinical Signs, Symptoms or Conditions1
- No Consequences Or Impact To Patient1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 4, 2021False Negative Result; False Negative Result
ON (B)(6) 2020 A CUSTOMER REPORTED TWO PATIENT SAMPLES UNEXPECTEDLY NOT REACTING TO ANTI-V ON PANOCELL 20.
Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient
MAUDE report 11114017 ↗MalfunctionJun 1, 2018False Negative Result; False Negative Result
ON (B)(6) 2018, AN IMMUCOR EMPLOYEE VISITING A CUSTOMER SITE, REPORTED ON BEHALF OF THAT CUSTOMER SITE AN UNEXPECTEDLY NEGATIVE RESULT OUTCOME BY TEST TUBE METHOD, USING PANOCELL-20, WHEN TESTED ON (B)(6) 2018.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7560979 ↗
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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