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Terminated

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.

FDA Recall Z-1556-2013 · Posted 2013-06-19

Recalling FirmOrtho-Clinical Diagnostics
Recall StatusTerminated
Product CodeLPS
Date Initiated2013-04-01
Date Terminated2017-03-22
Product Quantity478 total (339- Domestic) (139- International)

Reason for Recall

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

Firm Action

Ortho Clinical Diagnostics sent an "Important Product Correction Notification" letter dated April 1, 2013 to all affected customers. Ortho Clinical Diagnostics recommends that their customers immediately discontinue using and discard all VITROS HCY Reagent remaining in your inventory for the affected lot. They have requested that their customers complete and return the attached Confirmation of Receipt form no later than April 12, 2013. Ortho Clinical Diagnostics requested that these notifications be forwarded to all laboratories and posted beside each VITROS System that utilizes VITROS HCY Reagent within their customers facilities. To place a product order for an alternate lot, please contact Ortho Clinical Diagnostics customer service representatives at 1-800-828-6316. The VITROS Chemistry Products HCY Reagent is used on the VITROS 5,1 FS Chemistry System, the VITROS 4600 Chemistry System and the VITROS 5600 Integrated System to quantitatively measure total homocysteine concentration in human serum and plasma.

Root Cause

Process control

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K061588VITROS CHEMISTRY PRODUCTS HCY REAGENT, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 27, HCY PERFORMANCE VERIFIERSOrtho-Clinical Diagnostics, Inc. · 2006-07-21

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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