Recall Z-0992-2019— Ortho-Clinical Diagnostics

Name: FDA recall Z-0992-2019
Creator: U.S. Food and Drug Administration
Published: 2019-01-22

Class II · Terminated

Class II FDA medical device recall by Ortho-Clinical Diagnostics, initiated 2019-01-22, terminated 2022-06-10. It names one FDA 510(k) clearance: K081411. Product: VITROS Chemistry Products Na+ Slides, Catalog Number 8379034 For in vitro diagnostic use only. VITROS Na+ Slides quantitatively measure sodium (Na+) concentration in serum, plasma, and urine using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.. Reason: Imprecision in the affected lot may produce negatively or positively biased patient sample and quality control fluid results..

Recalling firm: Ortho-Clinical Diagnostics
Classification: Class II
Status: Terminated
Initiated: 2019-01-22
Terminated: 2022-06-10
Firm location: Rochester, NY, United States

510(k) clearances named in this recall

1 on FDA's record

K081411 — VITROS CHEMISTRY PRODUCT NA+ SLIDES; VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 2Ortho-Clinical Diagnostics, Inc.·cleared 2008-06-30

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 Na+ Slides, Catalog Number 8379034 For in vitro diagnostic use only. VITROS Na+ Slides quantitatively measure sodium (Na+) concentration in serum, plasma, and urine using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.

Reason for recall

Imprecision in the affected lot may produce negatively or positively biased patient sample and quality control fluid results.

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