Siemens Healthcare recalls Atellica IM 1300 Analyzer software version 1.13 and lower due to 5 potential issues affecting reagent locks, sample reading, and test results. Affected units may require software update.
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 1300 Analyzers with software version 1.13 or older because they have five specific software issues that could cause incorrect test results or failed tests. This matters because inaccurate results could lead to wrong medical diagnoses.
The software issues include problems with reagent locks, sample barcode reading, CEA dilution testing, and display of results. These problems could cause the analyzer to give incorrect test results or fail to run certain tests properly.
Healthcare facilities using the Atellica IM 1300 Analyzer with software version 1.13 or older are most at risk. Patients receiving lab tests through these analyzers could potentially receive incorrect results.
Check if your Atellica IM 1300 Analyzer has software version 1.13 or lower. The product is sold under the name 'Atellica Solution' for in vitro diagnostic testing.
Contact Siemens Healthcare to get the latest software version for your Atellica IM 1300 Analyzer.
The software version 1.13 and lower has five specific issues that could cause incorrect test results or failed tests for certain types of clinical samples.
No, you can continue using it but you must update the software to fix the issues.
The analyzer may give incorrect results or fail to run certain tests, which could lead to wrong medical diagnoses.
We’ve drafted a message you can send Siemens Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-0192-2019 — Siemens Healthcare Siemens Healthcare Hello, I own a Siemens Healthcare that is covered by recall Z-0192-2019 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.
