Devices

Device Recall AntiCardiolipin IgM ELISA Test Kit

Model / Serial
Kit identified on label as "REF 425-2020" and "LOT CL-863". Positive Control included in lot is identified as "REF 425-2025" and "LOT CPM-591".
Product Classification
Immunology and Microbiology Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide distribution: USA, Australia, Canada, France, Italy, Korea, Mexico, Panama, Singapore, and Trinidad.
Product Description
BIO-RAD 425-2020 Autoimmune EIA Anti-Cardiolipin IgM, 96 Tests...2010 02 16...Lot CL-863. Positive Control included in lot is identified as "REF 425-2025" and "LOT CPM-591". in vitro diagnostic.
Manufacturer
Bio-Rad Laboratories Inc
1 Event
- Recall of Device Recall AntiCardiolipin IgM ELISA Test Kit

Manufacturer

Bio-Rad Laboratories Inc

Manufacturer Address
Bio-Rad Laboratories Inc, 4000 Alfred Nobel Dr, Hercules CA 94547-1803
Source
USFDA

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