Device product

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.

Z-0848-2015

November 06, 2014

Class II

Product summary

Firm: Ortho-Clinical Diagnostics
Event: Event 69791
Status: Terminated
Classification: Class II
Quantity: USA: 380 units, Foreign: 155 units
Official record key: device-enforcement:Z-0848-2015

Official wording

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

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.

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

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