VITROS 4600 Chemistry System, Software Version 3.2 & Below. Automates pre-analytical and post-analytical sample and data management for in vitro diagnostic use.
Check against the official notice below — it lists the full affected range.
Ortho-Clinical Diagnostics is recalling the VITROS 4600 Chemistry System with Software Version 3.2 and below due to a software anomaly that allows multiple urine assays to be tested using a single specimen without accounting for each assay's specific pretreatment requirements. This defect can produce biased patient test results. The affected equipment has been distributed worldwide, including throughout the United States, Latin America, Asia-Pacific, and Europe, with 255 total units identified (131 in the US and 124 internationally). The device has Product Code 6802445 and Unique Device Identifier No. 10758750012343.
According to the recall record provided, no specific remedy or consumer action is specified.
Written by software from the official notice below. Not reviewed by a lawyer.
Software anomaly allows testing of multiple assays using a single urine specimen, regardless of the pretreatment requirements for each selected assay, potentially leading to biased patient results.
Reason for recall: Software anomaly allows testing of multiple assays using a single urine specimen, regardless of the pretreatment requirements for each selected assay, potentially leading to biased patient results. Distribution: Worldwide Distribution-US (nationwide), Brazil, Chile, Mexico, Australia, Hong Kong, India, Taiwan, Belgium, Denmark, France, Ireland, Italy, Portugal, Romania, Spain, Sweden and the UK. Quantity: 255 units total (131 domestically & 255 internationally) Lot/code info: Product Code: 6802445 Unique Device Identifier No.: 10758750012343
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.