Recall Z-1556-2013 ยท LPS Urinary Homocystine (Nonquantitative) Test System
Ortho-Clinical Diagnostics
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.
| Date | Jun 19, 2013 (initiated Apr 1, 2013) |
| Status | Terminated |
| Reason | The firm is recalling the specific lot due to lower than expected results. |
| Root cause | Process control |
| 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 |
| Quantity | 478 total (339- Domestic) (139- International) |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K061588 | VITROS CHEMISTRY PRODUCTS HCY REAGENT, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 27, HCY PERFORMANCE VERIFIERS Ortho-Clinical Diagnostics, Inc., Jul 21, 2006 |