Platelia Aspergillus IgG
Brand(s)
Last updated
Summary
Product
Platelia Aspergillus IgG
Issue
Medical devices - Performance issue
What to do
Contact the manufacturer if you require additional information.
Audience
Healthcare
Affected products
Affected products |
Lot or serial number |
Model or catalog number |
|---|---|---|
Platelia Aspergillus IgG |
2L0039 |
62783 |
Issue
Bio-Rad Laboratories is initiating a recall due to a confirmed quality anomaly for Platelia aspergillus IgG test (cat #62783), for lot 2l0039 (expiry date: 2024/04/15). The current lot 2l0039 shows a decrease of Optical Density (OD) of all calibrators. The OD of the R4A calibrator 10 au/ml could be lower than 0.200 (the expected quality criteria is R4A OD value > 0.200) that could result in an invalid run.
Recall start date: May 11, 2023
Additional information
Details
Original published date: 2023-05-29
Alert / recall type
Health product recall
Category
Health products - Medical devices
Companies
Bio-Rad
3 Boulevard Raymond Poincare, Marnes-La-Coquette, Marne, France, 92430
Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-73710