Anti-Lua (Lu1)
Brand(s)
Last updated
Summary
Product
Anti-Lua (Lu1)
Issue
Medical devices - Inaccurate test or measurement results
What to do
Contact the manufacturer if you require additional information.
Affected products
| Affected Products | Lot or Serial Number | Model or catalog number |
|---|---|---|
| Anti-Lua (Lu1) | 3131020-00 3113160-00 3131030-00 | 808 216 |
Issue
A recall was issued in connection to false negative results for the Anti-Lua control (Lu 1) from lot 3113160-00, because minimum antibody levels were not met. The two lots (3131020-00 and 3131030-00) produced to replace lot 3113160-00 have shown a decrease in reactivity over their life of approximately nine months. Soon, the acceptance criteria may no longer be met. Therefore, these lots are also being recalled.
Recall start date: Mar 22, 2022
Additional information
Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Haematology
Companies
Bio-Rad Medical Diagnostics Gmbh
Industriestr.1, Dreieich
Germany, 63303
Published by
Health Canada
Audience
General public
Health professionals
Hospitals
Recall class
Type II
Identification number
RA-64043
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