ORTHOTM Sera Papain 6904840Recalls & reported problems
Alba Bioscience Limited · For in vitro diagnostic use only. For use as an enzyme solution with ORTHO™ Sera Anti-Lea, Anti-Leb, Anti-Jka and Anti-Jkb Blood Grouping Reagents. The ORTHO™ Sera Papain is used to enhance reactivity of ORTHO™ Sera red blood cell antigen typing reagents and red blood cells when used in in vitro immunohematology assays. · Class 2
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 10758750030330), received between May 23, 2023 and Jun 25, 2025 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Expiration Date Error” (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
- Expiration Date Error1
- Insufficient Device Problem Information1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 25, 2025Insufficient Device Problem Information; Insufficient Device Problem Information
THE END USER REPORTS FALSE NEGATIVE RESULTS WITH ORTHO SERA PAPAIN PRODUCT FD317, LOT V278742, EXPIRY 30SEP25.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22327432 ↗MalfunctionMay 23, 2023Expiration Date Error; Expiration Date Error
END USER REPORTS A FALSE NEGATIVE RESULT WITH ORTHOSERA PAPAIN PRODUCT FD317 LOT V249596 EXPIRY 06MAY23. THE END USER REPORTS EIGHT DONOR SAMPLES GENERATED FALSE NEGATIVE AND WEAK POSITIVE RESULTS WITH THE REAGENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16984021 ↗
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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