Devices

Device Recall VITROS Signal Reagent

Model / Serial
Lots 8530 distributed to US customers and 1 Canadian customer (NOTE: Lot 8350 was distributed from Wales facility to non-US foreign customers.)
Product Classification
Clinical Chemistry and Clinical Toxicology Devices
Device Class
2
Implanted device?
No
Distribution
Medical facilities nationwide and 1 foreign affiliate in Canada.
Product Description
VITROS Immunodiagnostic Products Signal Reagent, Catalog No. 107 2693 --- an in vitro diagnostic for use on the VITROS Immunodiagnostics ECi/ECiQ System, which is used to screen and diagnose more than 40 diseases and conditions including cardiac disease, hepatitis (A, B, or C), thyroid disorders, HIV, and pregnancy.
Manufacturer
Ortho-Clinical Diagnostics
1 Event
- Recall of Device Recall VITROS Signal Reagent

Manufacturer

Ortho-Clinical Diagnostics

Manufacturer Address
Ortho-Clinical Diagnostics, 100 Indigo Creek Drive, Rochester NY 14626
Source
USFDA

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