Assay Data Disk (ADD), All DRV versions that support product within expiry dating 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 p
Check against the official notice below — it lists the full affected range.
Ortho-Clinical Diagnostics has recalled its Assay Data Disk (ADD) software across all DRV versions due to a software anomaly affecting urine sample handling. The software incorrectly allowed urine samples requiring acidified pretreatment to be taken from the same container as samples requiring no pretreatment when programmed for different assays. This defect affects 2,387 units distributed worldwide, including 987 units in the United States and 1,400 internationally across countries including Brazil, Chile, Mexico, Australia, and multiple European nations. The affected product code is 6801876.
The recall record does not specify a remedy or corrective action for affected consumers.
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: 6801876 Unique Device Identifier Numbers: 10758750001576
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.