Z-1179-2017Class II

VITROS Chemistry Products UPRO Slides, UPN 10758750000593

Name: Z-1179-2017 VITROS Chemistry Products UPRO Slides, UPN 10758750000593
Creator: Ortho-Clinical Diagnostics
Published: 2016-12-08
License: https://open.fda.gov/license/

Ortho-Clinical Diagnostics, Inc. / initiated 2016-12-08 / Terminated / root cause: design

FDA source

Ortho-Clinical Diagnostics began a recall of VITROS Chemistry Products UPRO Slides, UPN 10758750000593, Product Usage: Quantitative measurement of total protein concentration in urine on 2016-12-08. FDA classified it as Class II and gives the reason as "There is a potential for variable negatively and positively biased urine protein results using VITROS UPRO Slides". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1179-2017
Classification: Class II
Status: Terminated
Initiated: 2016-12-08
Posted: 2017-02-09
Terminated: 2018-06-22
Recalling firm: Ortho-Clinical Diagnostics, Inc.
Product: VITROS Chemistry Products UPRO Slides, UPN 10758750000593, Product Usage: Quantitative measurement of total protein concentration in urine.
Product code: JGP Lowry (Colorimetric), Total Protein
Reason for recall: There is a potential for variable negatively and positively biased urine protein results using VITROS UPRO Slides.
Root cause tag: design
FDA root cause: Device Design
Action: On December 8, 2016, Ortho Clinical Diagnostics distributed Product Correction Notification letters to their customers via FedEx, ORTHO PLUS e-Communications and/ or US Postal Service Priority Mail. Customers are advised to check their stock for affected product and to immediately discontinue and discard all remaining inventory. Ortho will credit your account for any discarded VITROS UPRO Slides, VITROS Chemistry Products Calibrator Kit 10 and/or VITROS Chemistry Products UPRO Performance Verifier I & II. Please complete the Confirmation of Receipt and return by December 22, 2016. Customers with questions, please contact Ortho CareTM Technical Solutions Center at 1-800-421-3311.
Quantity in commerce: 37,571 packs/90 slides totalling 3,381,390 slides
Distribution: 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.
Product codes and lots: Product Code REF 680 0120 Lot: GENs 14-18 Expiry Date range 01-JAN-2017 through 01-MAY-2018

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1179-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1179-2017	Class II	Terminated	Voluntary: Firm initiated	2017-02-15	2017-02-09

Product code JGP

K964960Class IIVitros Chemistry Products Upro SlidesJohnson & Johnson Clinical Diagnostics, Inc. / cleared 1997-02-18

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)