ALBAcyte Expanded Rh Negative Antibody Screen Z464URecalls & reported problems
Alba Bioscience Limited · Reagent Red Blood Cells, ALBAcyte Expanded Rh Negative Antibody Screen 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 05060242471377), received between Dec 13, 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® EXPANDED RH NEGATIVE ANTIBODY SCREEN (PRODUCT CODE Z464U, LOT NUMBER V198377) SUPPLIED TO CUSTOMERS CONTAINED AN ERROR. TWO OF THE DONORS RECORDED ON THE ANTIGEN PROFILE ARE INCORRECT. THE PHENOTYPES OF THE CELLS IN THE ACTUAL PRODUCT ARE VERY SIMILAR AND COMPATIBLE WITH THE REQUIREMENTS OF AN ANTIBODY SCREEN. THE ORIGINAL (I.E. INCORRECT) AND THE CORRECTED ANTIGEN PROFILES ARE ATTACHED TO THIS REPORT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8206178 ↗MalfunctionDec 13, 2018Inadequate Instructions for Healthcare Professional; Inaccurate Information; Inadequate Instructions for Healthcare Professional; Inaccurate Information
THE ANTIGEN PROFILE FOR US LICENSED REAGENT RED BLOOD CELLS, EXPANDED RH NEGATIVE ANTIBODY SCREEN (PRODUCT CODE Z464U, LOT NUMBER V199492) SUPPLIED TO CUSTOMERS CONTAINED AN ERROR. DURING IN-HOUSE TESTING OF THE US LICENSED REAGENT RED BLOOD CELL PRODUCTS EXPANDED RH NEGATIVE ANTIBODY SCREEN (PRODUCT CODE Z464U, LOT NUMBER V199492), ALBA BIOSCIENCE DISCOVERED AN ERROR IN THE ANTIGEN PROFILES FOR THE PANEL. CELL 2 IS STATED AS P1 NEGATIVE WHERE THE CELL HAS BEEN TESTED AND SHOWN TO BE P1 POSITIVE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8159675 ↗
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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