Siemens Healthcare Diagnostics, Inc. Recall: Atellica Sample Handler Prime (SMN 11069001).
Siemens Healthcare Diagnostics, Inc. Recall: Atellica Sample Handler Prime (SMN 11069001). is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: Siemens Healthcare Diagnostics, Inc.; Product: Atellica Sample Handler Prime (SMN 11069001). The Atellica" Solution is a multi-component system for
| Recalling firm | Siemens Healthcare Diagnostics, Inc. |
|---|---|
| Product | Atellica Sample Handler Prime (SMN 11069001). The Atellica" Solution is a multi-component system for in vitro diagnostic testing of clinical specimens. |
| Reason for recall | Atellica Solution system software (SW) version 1.13 and lower, five (5) behavioral issues were identified: 1. Reagent Lock may not work as intended with Primary Reagent ReadyPacks¿ and Ancillary Packs when more than one (1) lot of specific Reagent kits are loaded on the analyzer at the same time. 2. Sample barcodes may be incorrectly read 3. The Atellica IM 1300 Analyzer and Atellica IM 1600 Analyzer may not run CEA dilutions at 50x and 100x. The Analyzer may post a Sample Integrity Error when 50x or 100x dilutions are ordered for Carcinoembryonic Antigen (CEA). Dilution factors lower than 50x |
| Classification | Class II (moderate — may cause temporary or reversible health consequences) |
| Status | Terminated |
| Distribution | Nationwide Foreign: Australia Austria Belgium Brazil Canada Croatia Czech Republic Denmark France Germany Greece Italy Japan Malaysia Mexico Netherlands Norway Poland Republic Korea Singapore Spain Sweden Switzerland U.A.E. United Kingdom |
| Recall initiated | 20180629 |
| Recall number | Z-0189-2019 |
| Category | device |
| State | NY |
| Country | United States |
$29/mo
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