Recalls / —

—#151775

Product

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

FDA product code

JGP — Lowry (Colorimetric), Total Protein

Device class

Class 2

Medical specialty

Clinical Chemistry

510(k) numbers

K964960

Affected lot / code info

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

Why it was recalled

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

Root cause (FDA determination)

Device Design

Action the firm took

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.

Recalling firm

Firm

Ortho-Clinical Diagnostics

Address

513 Technology Blvd, Rochester, New York 14626-3601

Distribution

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.

Timeline

Recall initiated

2016-12-08

Terminated

2018-06-22

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #151775. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.