Device product
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.
Z-1556-2013
Product summary
- Event
- Event 64874
- Status
- Terminated
- Classification
- Class II
- Quantity
- 478 total (339- Domestic) (139- International)
- Official record key
device-enforcement:Z-1556-2013
Official wording
Reason: The firm is recalling the specific lot due to lower than expected results.
Code information: Lot # 1529-17-2636, expiration date 12 June 2013
Distribution pattern: 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.
Derived failure modes
-
Unknown
The firm is recalling the specific lot due to lower than expected results.