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Recall Observatory FDA recall evidence

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

April 01, 2013

Class II

Product summary

Firm
Ortho-Clinical Diagnostics
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

    reason.no_named_rule · v1.0.0

    The firm is recalling the specific lot due to lower than expected results.