VITROS 5600 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.
The VITROS 5600 Chemistry System, Software Version 3.2 and below, has been recalled due to a software anomaly that allows multiple assays to be tested using a single urine specimen without applying the proper pretreatment requirements specific to each assay. This defect can produce biased or inaccurate patient test results. The affected device is an automated system used in clinical laboratories for sample and data management in diagnostic testing.
The recall affects 1,895 units worldwide, including 907 in the United States and 988 internationally across Brazil, Chile, Mexico, Australia, Hong Kong, India, Taiwan, Belgium, Denmark, France, Ireland, Italy, Portugal, Romania, Spain, Sweden, and the UK. The affected product code is 6802413 with Unique Device Identifier 10758750002740. The source document does not specify what remedy an affected consumer should pursue.
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: 1895 units total (907 domestically & 988 internationally) Lot/code info: Product Code: 6802413 Unique Device Identifier No.: 10758750002740
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.