Ortho-Clinical Diagnostics: Medical Device Recall in 2016 - (Recall #: Z-0090-2017)

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 LAC Slides, REF/Product Codes 843 3880 (300 slides per sales unit) and 815 0112 (90 slides per sales unit), Unique Device Identifier Nos. 10758750004911 and 10758750004454, Rx ONLY, IVD --- For in vitro diagnostic use only. VITROS Chemistry Products LAC Slides quantitatively measure lactate (LAC) concentration in plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.

Product Classification:

Class II

Date Initiated: August 11, 2016

Date Posted: October 26, 2016

Recall Number: Z-0090-2017

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: 32,081 sales units; Foreign: 29,932 sales units

Code Information:

Current/In-date GENs 30, 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