Recall Z-1179-2017— Ortho-Clinical Diagnostics

Name: FDA recall Z-1179-2017
Creator: U.S. Food and Drug Administration
Published: 2016-12-08

Class II · Terminated

Class II FDA medical device recall by Ortho-Clinical Diagnostics, initiated 2016-12-08, terminated 2018-06-22. It names one FDA 510(k) clearance: K964960. Product: VITROS Chemistry Products UPRO Slides, UPN 10758750000593, Product Usage: Quantitative measurement of total protein concentration in urine.. Reason: There is a potential for variable negatively and positively biased urine protein results using VITROS UPRO Slides..

Recalling firm: Ortho-Clinical Diagnostics
Classification: Class II
Status: Terminated
Initiated: 2016-12-08
Terminated: 2018-06-22
Firm location: Rochester, NY, United States

510(k) clearances named in this recall

1 on FDA's record

K964960 — VITROS CHEMISTRY PRODUCTS UPRO SLIDESJohnson & Johnson Clinical Diagnostics, Inc.·cleared 1997-02-18

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 UPRO Slides, UPN 10758750000593, Product Usage: Quantitative measurement of total protein concentration in urine.

Reason for recall

There is a potential for variable negatively and positively biased urine protein results using VITROS UPRO Slides.

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