Enzyme Solution Papain Ortho Sera
Brand(s)
Last updated
Summary
Product
Enzyme Solution Papain Ortho Sera
Issue
Medical devices - Performance
What to do
Contact the manufacturer if you require additional information.
Audience
Industry
Affected products
| Affected products | Lot or serial number | Model or catalog number |
|---|---|---|
| Enzyme Solution Papain Ortho Sera | V249599 V250681 V249596 V252336 V257490 | 6904840 |
Issue
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. Through a customer complaint investigation, the reactivity of Ortho™ Sera Papain of the affected lots stated above has been confirmed as reduced.
Recall start date: May 19, 2023
Additional information
Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Haematology
Companies
Alba Bioscience Limited
James Hamilton Way, Penicuik, Scotland, Great Britain, EH26 OBF
Published by
Health Canada
Audience
Industry
Recall class
Type II
Identification number
RA-73750
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