Recall Z-2066-2012— Ortho-Clinical Diagnostics

Name: FDA recall Z-2066-2012
Creator: U.S. Food and Drug Administration
Published: 2012-05-21

Class II · Terminated

Class II FDA medical device recall by Ortho-Clinical Diagnostics, initiated 2012-05-21, terminated 2018-07-05. It names one FDA 510(k) clearance: K031924. Product: VITROS 5,1 FS System Software For use in the in-vitro quantitative, semi quantitative, and qualitative measurement of variety of analytes of clinical interest.. Reason: software automatically switches the lot when a vancomycin (VANC) or valproic acid (VALP) reagent is depleted or the operator manually changes the lot in use causing lack of verification of proper quality assessment..

Recalling firm: Ortho-Clinical Diagnostics
Classification: Class II
Status: Terminated
Initiated: 2012-05-21
Terminated: 2018-07-05
Firm location: Rochester, NY, United States

510(k) clearances named in this recall

1 on FDA's record

K031924 — VITROS 5,1 FS CHEMISTRY SYSTEM, VITROS CHEMISTRY PRODUCTS DHDL REAGENT PACK, CALIBRATOR KIT 19, FS CALIBRATOR 1Ortho-Clinical Diagnostics·cleared 2003-08-07

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 5,1 FS System Software For use in the in-vitro quantitative, semi quantitative, and qualitative measurement of variety of analytes of clinical interest.

Reason for recall

software automatically switches the lot when a vancomycin (VANC) or valproic acid (VALP) reagent is depleted or the operator manually changes the lot in use causing lack of verification of proper quality assessment.

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