—#166371

Product

Atellica Sample Handler Prime (SMN 11069001). The Atellica" Solution is a multi-component system for in vitro diagnostic testing of clinical specimens.

FDA product code: JJE — Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Device class: Class 1
Medical specialty: Clinical Chemistry
510(k) numbers: K161954
Affected lot / code info: Software (SW) version 1.13 and lower

Why it was recalled

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.

Root cause (FDA determination)

Software design

Action the firm took

Siemens issued an Urgent medical Device Correction, (UMDC ASW18-02.A.US) and Urgent Field Safety Notification (UFSN ASW18-02.A.OUS) on 6/29/18, via FedEx to the US Customer and via email distribution to countries Outside US (OUS). The field action letters explain the behaviors and informed Customers of action to be taken to prevent the behaviors from occurring. Siemens has released an updated software (SW) version (V), 1.14, which corrects the reported behaviors.

Recalling firm

Firm: Siemens Healthcare Diagnostics, Inc.
Address: 511 Benedict Ave, Tarrytown, New York 10591-5005

Distribution

Distribution pattern: 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

Timeline

Recall initiated: 2018-06-29
Terminated: 2021-08-12
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #166371. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.