Ortho-Clinical Diagnostics: Medical Device Recall in 2014 - (Recall #: Z-2214-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

Product Description:

VITROS¿ Chemistry Products CDM PROM Calibration Data Module Rev. No. 0168 and 0169 (Product Code 1999077) are used in conjunction with VITROS Chemistry Products NH3 DT Slides (Product Code 1532589) GEN 59 and VITROS¿ Chemistry Products DT Calibrator Kit lot 44 (Product Code 1957927) and tested on the VITROS DT60/DT60 II Chemistry System: IVD, Made in USA by Ortho-Clinical Diagnostics, Inc. Rochester, NY

Product Classification:

Class II

Date Initiated: July 15, 2014

Date Posted: August 20, 2014

Recall Number: Z-2214-2014

Event ID: 68840

Reason for Recall:

Inability to calibrate or use VITROS NH3 DT Slides, GEN 59 with VITROS Chemistry Products DT Calibrator Kit, Lot 44 when CDM PROM 0168 or 0169 is installed on VITROS DT60/DT60 II Chemistry Systems.

Status: Terminated

Product Quantity: 5906 total: 240 (US); 5666 (OUS)

Code Information:

Lots 0168 and 0169

Distribution Pattern:

Worldwide Distribution - USA including MA, TX, KY, IL, MS, OH and Puerto Rico; Internationally to: Australia, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Mexico, Panama, Singapore, Spain, and Venezuela.

Voluntary or Mandated:

Voluntary: Firm initiated