Recall Z-0268-2020— Ortho-Clinical Diagnostics

Name: FDA recall Z-0268-2020
Creator: U.S. Food and Drug Administration
Published: 2019-09-10

Class II · Terminated

Class II FDA medical device recall by Ortho-Clinical Diagnostics, initiated 2019-09-10, terminated 2020-11-13. It names one FDA 510(k) clearance: K071801. Product: VITROS chemistry Products Cl- Slides, Catalog No. 8445207 (which does NOT support Urine CL-). MicroSlides which contain reagents in a dry, multi-layered form.. Reason: Users may experience intermittent slide dispense issues with some cartridges due to the anti-backup platen failing to advance inside the cartridge..

Recalling firm: Ortho-Clinical Diagnostics
Classification: Class II
Status: Terminated
Initiated: 2019-09-10
Terminated: 2020-11-13
Firm location: Rochester, NY, United States

510(k) clearances named in this recall

1 on FDA's record

K071801 — VITROS CHEMISTRY PRODUCTS CI-SLIDES, CALIBRATOR KIT 2, MODEL(S) 844-5207, 166-2659Ortho-Clinical Diagnostics, Inc.·cleared 2007-07-20

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 Cl- Slides, Catalog No. 8445207 (which does NOT support Urine CL-). MicroSlides which contain reagents in a dry, multi-layered form.

Reason for recall

Users may experience intermittent slide dispense issues with some cartridges due to the anti-backup platen failing to advance inside the cartridge.

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