VITROS 5,1 FS Chemistry System, Software Version 2.8 & Below Automates pre-analytical and post-analytical sample and data management for in vitro diagnostic use. VITROS Urine Assays: VITROS Calcium (Ca), Magnesium (Mg), and Phosphorus (Phos) requires acidification pretreatment prior to urine assay t
Check against the official notice below — it lists the full affected range.
The VITROS 5,1 FS Chemistry System (Software Version 2.8 and below) is being recalled due to a software anomaly affecting urine sample handling. The defect allows urine samples requiring acidified pretreatment to be metered from the same container as samples requiring no pretreatment when both assay types are programmed, which could result in incorrect sample preparation and potentially inaccurate test results.
Approximately 2,387 units have been distributed worldwide, including 987 units domestically in the United States and 1,400 units internationally across Brazil, Chile, Mexico, Australia, Hong Kong, India, Taiwan, Belgium, Denmark, France, Ireland, Italy, Portugal, Romania, Spain, Sweden, and the UK. The affected devices carry product codes 6801375 and 6801890. The recall record does not specify what action affected consumers should take in response to this recall.
Written by software from the official notice below. Not reviewed by a lawyer.
Software anomaly regarding urine samples that require acidified pretreatment. The software has allowed urine samples for assays that require acidified pretreatment to be metered from the same sample container as assays that required no pretreatment when the sample was programmed.
Reason for recall: Software anomaly regarding urine samples that require acidified pretreatment. The software has allowed urine samples for assays that require acidified pretreatment to be metered from the same sample container as assays that required no pretreatment when the sample was programmed. 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: 2,387 units Total (987 domestically & 1400 internationally) Lot/code info: Product Code: 6801375, 6801890 Unique Device Identifier Numbers: 10758750001132, 10758750001644
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.