Devices

VITROS Clinical Chemistry Products Homocysteine (HCY) Reagent

Model / Serial
Lot # 1529-17-2636, expiration date 12 June 2013
Product Classification
Clinical Chemistry and Clinical Toxicology Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide Distribution-USA (nationwide) including the states of AR, AZ, CA, CO, CT, FL, HI, ID, IL, KY, LA, ME, NJ, OK, TN, TX, WA, and WV, and the countries of Colombia, India, Japan, Mexico, Puerto Rico, Republic of Panama, Singapore, Venezuela, England, France, Germany, Italy, and Spain.
Product Description
VITROS Chemistry Products-HCY Reagent packaged in a kit carton. Catalog# 6802002. || Used to quantitatively measure total homocysteine (HCY) concentration in human serum and plasma.
Manufacturer
Ortho-Clinical Diagnostics
1 Event
- Recall of VITROS Clinical Chemistry Products Homocysteine (HCY) Reagent

Manufacturer

Ortho-Clinical Diagnostics

Manufacturer Address
Ortho-Clinical Diagnostics, 100 Indigo Creek Dr, Rochester NY 14626-5101
Manufacturer Parent Company (2017)
The Carlyle Group LP
Source
USFDA

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