ALBAcyte Antibody Identification (16-Cell) Z473URecalls & reported problems
Alba Bioscience Limited · Reagent Red Blood Cells, ALBAcyte Antibody Identification (16-Cell) 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 05060242471384), received between Dec 31, 2018 and Dec 12, 2023 — classified as 2 malfunctions.
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.
Reports received per month
Most reported problems
Device problems
- Inaccurate Information1
- Inadequate Instructions for Healthcare Professional1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- 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.
MalfunctionDec 12, 2023
AN END USER REPORTED A DAT POSITIVE RESULT WITH CELL 15 OF ALBACYTE REAGENT RED BLOOD CELLS FOR ANTIBODY IDENTIFICATION (16-CELL) PRODUCT Z473U, LOT V265925, EXPIRY 04DEC23, CELL 15 FOLLOWING A CONFIRMED. OFF LABEL USE OF THE DEVICE. THE END USER DID ORIGINALLY TEST BY THE CORRECT METHOD AS PER IFU AND GOT THE EXPECTED RESULT. NO RELEVANT TESTS/LABORATORY DATA RECEIVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18319074 ↗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 16-CELL (PRODUCT CODE Z473U, LOT NUMBER V194390) 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-). THE DEVIATION AFFECTS THE PRODUCT/LOT SUBJECT OF THIS REPORT BECAUSE IT SHARES THE SAME DONOR CELL WITH THE ABOVE PRODUCTS. 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 8206171 ↗
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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