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Terminated

Atellica Solution and Atellica Sample Handler Prime for in vitro diagnostic testing of clinical specimens.

FDA Recall Z-1587-2018 · Posted None

Recalling FirmSiemens Healthcare Diagnostics, Inc.
Recall StatusTerminated
Product CodeJGS
Date Initiated2018-02-26
Date Terminated2020-05-12

Reason for Recall

When more than one immunoassay analyzer is connected to a single solution system, reporting and conversion factors may not be applied to all analyzers

Firm Action

Recall initiated 02/23/2018 Firm released an update software (SW) version (V), 1.12.1, which corrects the behavior. A Mandatory Update (MU) campaign was launched to install the new SW V on all systems, whether or not they are impacted by this behavior. The MU campaign will be tracked to 100% completion globally.

Root Cause

Software design

Distribution Pattern

FL and France Spain Sweden United Kingdom Germany

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K161954Atellica Solution, Atellica A-LYTE Integrated Multisensor Na+/K+/CI-, Atellica CH Albumin BCP Reagent (Alb_p), Atellica IM Thyroid Stimulating Hormone TSH, Atellica CH Vancomycin (Vanc)Siemens Healthcare Diagnostics · 2017-03-09

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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