Recall Z-1556-2013— Ortho-Clinical Diagnostics

Name: FDA recall Z-1556-2013
Creator: U.S. Food and Drug Administration
Published: 2013-04-01

Class II · Terminated

Class II FDA medical device recall by Ortho-Clinical Diagnostics, initiated 2013-04-01, terminated 2017-03-22. It names one FDA 510(k) clearance: K061588. 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.. Reason: The firm is recalling the specific lot due to lower than expected results..

Recalling firm: Ortho-Clinical Diagnostics
Classification: Class II
Status: Terminated
Initiated: 2013-04-01
Terminated: 2017-03-22
Firm location: Rochester, NY, United States

510(k) clearances named in this recall

1 on FDA's record

K061588 — VITROS CHEMISTRY PRODUCTS HCY REAGENT, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 27, HCY PERFORMANCE VERIFIERSOrtho-Clinical Diagnostics, Inc.·cleared 2006-07-21

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.