ALBAcyte Reagent RBCs for Antibody Identification Panels (untreated) Z471URecalls & reported problems
Alba Bioscience Limited · Reagent Red Blood Cells, ALBAcyte Antibody Identification Cells for tube techniques, 2-3% suspension.
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 05060242471186), received between Dec 31, 2018 and Dec 31, 2018 — classified as 1 malfunction.
The most frequently reported specific device problem is “Inaccurate Information” (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
- Inaccurate Information1
- Inadequate Instructions for Healthcare Professional1
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.
MalfunctionDec 31, 2018Inadequate Instructions for Healthcare Professional; Inaccurate Information; Inadequate Instructions for Healthcare Professional; Inaccurate Information
THE ANTIGEN PROFILE FOR US LICENSED REAGENT RED BLOOD CELLS ALBACYTE® ANTIBODY IDENTIFICATION CELLS 10-CELL NATIVE (PRODUCT CODE Z471U, LOT NUMBER V194387) SUPPLIED TO CUSTOMERS CONTAINED AN ERROR. DURING IN-HOUSE TESTING OF THE US LICENSED REAGENT RED BLOOD CELL PRODUCTS ALBACYTE® ANTIBODY IDENTIFICATION CELLS 10-CELL NATIVE (PRODUCT CODE Z471U, LOT NUMBER V194387), 10-CELL PAPAIN-TREATED (PRODUCT CODE Z472U, LOT NUMBER V194389), ALBA BIOSCIENCE DISCOVERED AN ERROR IN THE ANTIGEN PROFILES FOR THESE PANELS. CELL # 9 WAS INCORRECTLY REPORTED AS JS(A+) WHILE THE DONOR IS ACTUALLY JS(A-). THERE ARE NO ISSUES WITH ANY OTHER ASPECT OF THE PANEL. NO COMPLAINTS HAVE BEEN RECEIVED FROM THE FIELD IN RELATION TO THIS INACCURACY.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8206168 ↗
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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