Devices

Device Recall ARCHITECT Folate High Control Kit

Model / Serial
List 6C12-11, Lot 06867M200
Product Classification
Clinical Chemistry and Clinical Toxicology Devices
Device Class
2
Implanted device?
No
Distribution
There was no U.S. distribution. The products were shipped internationally through Abbott affiliates in Canada, Germany, Singapore, Hong Kong, Australia, Brazil, New Zealand, Columbia, Chile, Uruguay, United Kingdom, Venezuela, Dominican Republic, Argentina and Curacao.
Product Description
ARCHITECT Folate High Controls, List 6C12-11; the kit contains 8 - 1 mL vials of High Control H 15.0 ng/mL; Abbott Laboratories, Abbott Park, IL 60064 USA
Manufacturer
Abbott Laboratories HPD/ADD/GPRD
1 Event
- Recall of Device Recall ARCHITECT Folate High Control Kit

Manufacturer

Abbott Laboratories HPD/ADD/GPRD

Manufacturer Address
Abbott Laboratories HPD/ADD/GPRD, 100/200 Abbott Park Road, Abbott Park IL 60064
Source
USFDA

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