Siemens Healthcare recalls Atellica IM 1600 Analyzer software versions 1.13 and lower due to 5 potential issues affecting reagent locks, sample barcodes, and test results. Affected units may need software updates.
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 and neat samples are not affected by this behavior. 4. The Atellica CH 930 Analyzer may continue to display the default reporting units after the reporting units have been changed. 5. The Atellica CH 930 Analyzer may not display results for sample if certain assays are configured to auto-dilute results above or below the assay measuring interval.
Siemens Healthcare is recalling Atellica IM 1600 Analyzers with software version 1.13 or older because they have five potential issues that could cause errors in reagent locks, sample barcodes, and test results. This affects laboratory equipment used for medical testing.
The software issues could cause reagent locks to malfunction when multiple reagent lots are loaded, sample barcodes to be misread, and certain tests like CEA dilutions to fail. This might lead to incorrect test results if not addressed.
Laboratories using Siemens Atellica IM 1600 Analyzers with software version 1.13 or older are most at risk. These devices are used for medical testing in clinical settings.
Check for Atellica IM 1600 Analyzers with software version 1.13 or lower. The product is sold as part of the Atellica Solution system for in vitro diagnostic testing.
Contact Siemens Healthcare to get the latest software version (1.14 or higher) to fix the issues.
No, you can continue using it but you must update the software to version 1.14 or higher to fix the issues.
Version 1.13 has five issues: reagent locks may not work with multiple reagent lots, sample barcodes may be misread, CEA dilutions may fail, and certain analyzers may display incorrect units or skip results.
Check if your Atellica IM 1600 Analyzer has software version 1.13 or lower. The product is sold as part of the Atellica Solution system for in vitro diagnostic testing.
We’ve drafted a message you can send Siemens Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-0193-2019 — Siemens Healthcare Siemens Healthcare Hello, I own a Siemens Healthcare that is covered by recall Z-0193-2019 from Siemens Healthcare. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
