Ortho-Clinical Diagnostics: Medical Device Recall in 2017 - (Recall #: Z-1179-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2017.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: December 8, 2016

Date Posted: February 15, 2017

Recall Number: Z-1179-2017

Event ID: 75936

Reason for Recall:

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

Status: Terminated

Product Quantity: 37,571 packs/90 slides totalling 3,381,390 slides

Code Information:

Product Code REF 680 0120 Lot: GENs 14-18 Expiry Date range 01-JAN-2017 through 01-MAY-2018

Distribution Pattern:

Worldwide distribution - Nationwide U.S.A; International - Bermuda, Australia, Canada, Chile, China, Colombia, India, Japan, Mexico, Republic of Panama, Singapore, Venezuela, England, France, Germany, Italy, Spain and Poland.

Voluntary or Mandated:

Voluntary: Firm initiated