ALBAcyte A2 Cells Z406URecalls & reported problems
Alba Bioscience Limited · 2-3% Reagent Red Blood Cells for ABO Reverse Grouping, ALBAcyte A2 Cells, for tube techniques.
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 05060242471131), received between Mar 20, 2025 and Jun 20, 2025 — classified as 3 malfunctions.
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
- No Apparent Adverse Event3
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 20, 2025No Apparent Adverse Event; No Apparent Adverse Event
FOLLOW UP REPORT..
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22296068 ↗MalfunctionMay 26, 2025No Apparent Adverse Event; No Apparent Adverse Event
THE END USER REPORTS FALSE POSITIVE RESULTS WITH ALBACYTE GROUP A2 REAGENT RED BLOOD CELLS, PRODUCT Z406U LOT V280597. THE END USER REPORTS 2+ POSITIVE RESULTS WHEN TESTED AGAINST ALBALECT ANTI-A1, PRODUCT Z241U LOT V273091. A TOTAL OF FOUR END USERS REPORTED FALSE POSITIVE WITH THE PRODUCT ALBACYTE GROUP A2 REAGENT RED BLOOD CELLS, PRODUCT Z406U LOT V280597. FOLLOW UP OF REPORT OF 3011683976-2025-00002.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22083492 ↗MalfunctionMar 20, 2025No Apparent Adverse Event; No Apparent Adverse Event
THE END USER REPORTS FALSE POSITIVE RESULTS WITH ALBACYTE GROUP A2 REAGENT RED BLOOD CELLS, PRODUCT Z406U LOT V280597. THE END USER REPORTS 2+ POSITIVE RESULTS WHEN TESTED AGAINST ALBALECT ANTI-A1, PRODUCT Z241U LOT V273091. A TOTAL OF FOUR END USERS REPORTED FALSE POSITIVE WITH THE PRODUCT ALBACYTE GROUP A2 REAGENT RED BLOOD CELLS, PRODUCT Z406U LOT V280597.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21650606 ↗
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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