Ortho-Clinical Diagnostics: Medical Device Recall in 2016 - (Recall #: Z-0092-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

VITROS Chemistry Products URIC Slides, REF/Product Code 194 3927 (300 slides per sales unit), Unique Device Identifier No. 10758750000340, Rx ONLY, IVD --- For in vitro diagnostic use only.

Product Classification:

Class II

Date Initiated: August 11, 2016

Date Posted: October 26, 2016

Recall Number: Z-0092-2017

Event ID: 74950

Reason for Recall:

Ortho Clinical Diagnostics confirmed that N-Acetylcysteine (NAC), a drug used for acetaminophen overdose, mucolytic therapy and is used as nutritional supplement, can interfere with VITROS GLU, LAC, TRIG, and URIC Slides assays.

Status: Terminated

Product Quantity: US: 18,749 sales units; Foreign: 94,928 sales units

Code Information:

Current/In-date GENs 26, 27, 28, 29, 31

Distribution Pattern:

Worldwide Distribution - US (Nationwide) Puerto Rico and Bermuda), Internationally to Australia, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Mexico, Republic of Panama, Poland, Singapore, Spain, and Venezuela.

Voluntary or Mandated:

Voluntary: Firm initiated