FDAJuly 19, 2022device

VITROS XT 7600 Integrated System with Version 3.7.2 and below Product Code: 6844461

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

Performing a system shutdown on VITROS XT 3400 and VITROS XT 7600 Systems may cause a positive or negative shift in the electrical current supplied to the LED used in conjunction with the Digital Imaging Reflectometer. Potential exists for either a positive or negative shift in results reported by the VITROS System.

What to do

FDA enforcement status: Ongoing

Brands named

ortho clinical diagnosticsorthoortho clinical

UPCs

10758750031610

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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