medical Class III Updated 2018-09-19

Ortho-Clinical Diagnostics recalls VITROS Chemistry Products Cl- Slides, Product Code 844 5207

Recalled Product

VITROS Chemistry Products Cl- Slides, Product Code 844 5207 Product Usage: For in vitro diagnostic use only. VITROS Chemistry Products Cl- Slides quantitatively measure chloride (Cl-) concentration in serum and plasma using VITROS 250/350/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.


Hazard / Issue

The slides do not meet the maximum allowable interference (MAI) claims for triglyceride interference when using serum samples. Triglyceride interference on the Cl- Slide was observed around a triglyceride concentration 600mg/dL, however the current triglyceride interference claim states interference should not occur below 800mg/dL of triglyceride.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: GEN 5 and below
View official government recall

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