VITROS Chemistry Products-HCY Reagent packaged in a kit carton. Catalog# 6802002. Used to quantitatively measure total h

FDA device recall Z-1556-2013 · posted 2013-06-19 · Terminated

Recall details

Recalling firm

Ortho-Clinical Diagnostics

Reason for recall

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

Action taken

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

Status

Terminated

Product code

LPS

Quantity affected

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

Date initiated

2013-04-01

Date posted

2013-06-19

Date terminated

2017-03-22

Location

Rochester, NY

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