PlainRecalls
FDA Devices Low Class III Terminated

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.

Reported: September 19, 2018 Initiated: July 11, 2018 #Z-3043-2018

Product Description

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.

Reason for Recall

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.

Details

Units Affected
128196
Distribution
Worldwide Distribution - US Nationwide and in the countries of: Australia, Belgium, Bermuda, Brazil, Canada, Chile, China, Columbia, Denmark, France, Germany, India, Italy, Japan, Mexico, Norway, Poland, Portugal, Russia, Singapore, Spain, Sweden, The Netherlands, and United Kingdom.
Location
Rochester, NY

Frequently Asked Questions

What product was recalled? ▼
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.. Recalled by Ortho-Clinical Diagnostics. Units affected: 128196.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 19, 2018. Severity: Low. Recall number: Z-3043-2018.

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