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VITROS 4600 Chemistry System Catalog Nos. 6802445 (regular) and 6900440 (refurbished)

FDA Recall #Z-1230-2024 — Class II — January 26, 2024

Recall #Z-1230-2024 Date: January 26, 2024 Classification: Class II Status: Ongoing

Product Description

VITROS 4600 Chemistry System Catalog Nos. 6802445 (regular) and 6900440 (refurbished)

Reason for Recall

A software defect affecting VITROS Systems running VITROS Software Versions 3.8.0 and 3.8.1 causes the Configurable Westgard Rules to not report as expected. When a new control is defined, configurable Westgard rules, if selected, are not flagged or reported with the applicable QC results if the statistical criteria is met. This may result in acceptance of QC results that do not meet acceptance criteria, which 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

15 US; 43 OUS

Distribution

Worldwide distribution - US Nationwide and the countries of Australia, Belgium, Brazil, Canada, Chile, China, Colombia, Denmark, France, Germany, India, Italy, Japan, Mexico, Norway, Portugal, Russia, Singapore, Spain, Sweden, The Netherlands, United Kingdom.

Code Information

VITROS System Software Versions 3.8.0 or 3.8.1 Regular UDI-DI 10758750012343 Refurbished UD-DI 10758750033201 Serial Numbers: US: J46000208 J46000209 J46000240 J46000497 J46000864 J46000865 J46000898 J46001030 J46001064 J46001125 J46001132 J46001293 J46001462 J46001703 J46001704 OUS: J46000150 J46000933 J46000162 J46001029 J46000190 J46001041 J46000247 J46001042 J46000296 J46001087 J46000393 J46001119 J46000410 J46001186 J46000478 J46001187 J46000499 J46001210 J46000531 J46001217 J46000564 J46001289 J46000617 J46001541 J46000772 J46001565 J46000788 J46001571 J46000800 J46001609 J46000801 J46001629 J46000812 J46001639 J46000821 J46001645 J46000855 J46001680 J46000859 J46000948 J46000861 J46000983 J46000910

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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