Blood Group Reagent Anti-Lea (Murine Monoclonal)Bioclone
Brand(s)
Last updated
Summary
Product
Blood Group Reagent Anti-Lea (Murine Monoclonal)Bioclone
Issue
Medical devices - Performance
What to do
Contact the manufacturer if you require additional information.
Audience
Healthcare
Affected products
| Affected products | Lot or serial number | Model or catalogue number |
|---|---|---|
| Blood Group Reagent Anti-Lea (Murine Monoclonal)Bioclone | LAB167A LAB169A LAB168A LAB170A | 715280 |
Issue
During an internal investigation, Ortho identified that the Anti-Lea (Anti-Le1) lot LAB170A was demonstrating weak to no reactivity with Lea positive cells. The results of the investigation demonstrated that lot LAB170A was more than two dilutions lower than the control lot, thereby these lots were failing internal testing. This issue of weak/no reactivity of Anti-Lea (Anti-Le1) antisera may be detectable in both quality control (QC) and patient samples based on weakened strength of reactivity.
Recall start date: June 29, 2022
Additional information
Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Haematology
Companies
Ortho-Clinical Diagnostics Inc.
1001 Us Hwy 202, Raritan, New Jersey, United States, 08869
Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-64355
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