Recall – IVD System software upgrade issues

Company: Siemens Healthcare Diagnostics, Inc.
Date of Enforcement Report 10/24/2018
Class II:

PRODUCT
Atellica Sample Handler Prime (SMN 11069001). The Atellica” Solution is a multi-component system for in vitro diagnostic testing of clinical specimens. Recall Number: Z-0189-2019

REASON
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.

RECALLING FIRM/MANUFACTURER
Siemens Healthcare Diagnostics, Inc. Tarrytown, NY on 6/29/2018. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
107

DISTRIBUTION
Nationwide and International

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