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VITROS XT 7600 Integrated System, Catalog No. 6844461

FDA Recall #Z-1228-2024 — Class II — January 26, 2024

Recall #Z-1228-2024 Date: January 26, 2024 Classification: Class II Status: Ongoing

Product Description

VITROS XT 7600 Integrated System, Catalog No. 6844461

Reason for Recall

A software defect affecting VITROS Systems running VITROS Software Versions 3.8.1 causes QC baseline statistics to not update as expected when changed by the user. This may cause erroneous patient results to be reported.

Recalling Firm

Ortho-Clinical Diagnostics, Inc. — Rochester, NY

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Devices

Product Quantity

44 US; 35 OUS

Distribution

Worldwide - US Nationwide distribution in the states of AZ, CA, CT, FL, IA, ID, IL, IN, KY, LA, MO, NE, NY, OH, OR, SC, SD, TX, WA, WI, WV and the countries of Australia, Brazil, Canada, China, Colombia, India, Mexico, Singapore, United Kingdom, Italy, Spain, Russia, France, and Belgium.

Code Information

VITROS System Software Version 3.8.1 UDI-DI 10758750031610 Serial Numbers US: J76000199 J76001383 J76000207 J76001385 J76000353 J76001392 J76000456 J76001404 J76000459 J76001406 J76000460 J76001516 J76000468 J76001518 J76000495 J76001519 J76000502 J76001520 J76000561 J76001581 J76001207 J76001583 J76001230 J76001611 J76001231 J76001620 J76001232 J76001644 J76001235 J76001647 J76001239 J76001660 J76001260 J76001668 J76001263 J76001671 J76001270 J76001674 J76001274 J76001692 J76001331 J76001700 J76001351 J76001748 OUS: J76000118 J76001070 J76000253 J76001074 J76000265 J76001095 J76000274 J76001121 J76000281 J76001130 J76000370 J76001152 J76000447 J76001174 J76000475 J76001328 J76000620 J76001377 J76000855 J76001378 J76000856 J76001396 J76000898 J76001399 J76000901 J76001407 J76000973 J76001408 J76000976 J76001484 J76001001 J76001673 J76001027 J76001761 J76001035

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.

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