Ortho-Clinical Diagnostics: Medical Device Recall in 2014 - (Recall #: Z-0848-2015)

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 TRIG Slides, REF 133 6544, IVD For in vitro diagnostic use only. VITROS Chemistry Products TRIG Slides quantitatively measure triglyceride (TRIG) concentration in serum and 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: November 6, 2014

Date Posted: December 31, 2014

Recall Number: Z-0848-2015

Event ID: 69791

Reason for Recall:

Potential for biased results using the specific lot of VITROS CHEMISTRY PRODUCTS TRIG slides.

Status: Terminated

Product Quantity: USA: 380 units, Foreign: 155 units

Code Information:

Lot 0704-3318-4774 (expiry date 01 Dec 2015)

Distribution Pattern:

Worldwide Distribution - USA (nationwide) Puerto Rico and 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