Health product recall

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:
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

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