ALBAcyte 2-3% Reagent RBCs for Antibody Identification Panels (papain-treated) Z472URecalls & reported problems
Alba Bioscience Limited · Reagent Red Blood Cells, ALBAcyte Antibody Identification Cells (papain-treated) for tube techniques, 2-3% suspension.
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 05060242471193), received between Dec 31, 2018 and Dec 31, 2018 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Inaccurate Information” (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
- Inaccurate Information2
- Inadequate Instructions for Healthcare Professional2
Patient problems
- No Known Impact Or Consequence To Patient2
Recent adverse event reports
The 2 most recent of 2 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 PAPAIN-TREATED (PRODUCT CODE Z472U, LOT NUMBER V187500) SUPPLIED TO CUSTOMERS CONTAINED AN ERROR. THIS WAS NOTED THROUGH A COMPLAINT RECEIVED FOR CE MARKED PRODUCT ALBACYTE REAGENT RED BLOOD CELLS FOR ANTIBODY IDENTIFICATION (PRODUCT CODE "Z472"), LOT NO. V187499) WHICH IS MANUFACTURED FROM THE SAME STARTING MATERIALS AND USING THE SAME MANUFACTURING PROCESS AS THE PRODUCT SUBJECT OF THIS REPORT. THE INVESTIGATION INDICATES THAT THE UNEXPECTED REACTIONS WITH ANTI-C ARE DUE TO CELL 2 AND CELL 3 OF THE PANEL BEING SWAPPED AT THE TIME OF LABELING OF THE PRIMARY CONTAINERS.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8206170 ↗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 PAPAIN-TREATED (PRODUCT CODE Z472U, LOT NUMBER V194389) 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 8206169 ↗
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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