Ortho-Clinical Diagnostics Recall: VITROS 5,1 FS Chemistry System, Software Version 2.8 &
Ortho-Clinical Diagnostics Recall: VITROS 5,1 FS Chemistry System, Software Version 2.8 & is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: Ortho-Clinical Diagnostics; Product: VITROS 5,1 FS Chemistry System, Software Version 2.8 & Below Automates pre-analytical and post-analytical sampl
| Recalling firm | Ortho-Clinical Diagnostics |
|---|---|
| Product | 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 testing. |
| 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. |
| Classification | Class II (moderate — may cause temporary or reversible health consequences) |
| Status | Terminated |
| 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. |
| Recall initiated | 20150406 |
| Recall number | Z-1728-2015 |
| Category | device |
| State | NY |
| Country | United States |
$29/mo
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