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Atellica 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)

by Siemens Healthcare Diagnostics

510(k) K161954

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

2 ongoing

This device is named in the recall

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK161954 Date9 Mar 2017ClearedStatusActive

Recalls

8 recalls · 2 ongoing · FDA

    • Ongoing Z-0496-2025 FDA Class II initiated 21 Oct 2024 on shared 510(k) K161954

    A manufacturing defect causes Atellica CH Reaction Ring Cuvette Segments with lot numbers N15 on the packaging or 15 on the underside of the cuvette segment have a potential for imprecision and erroneously depressed or elevated QC and patient results for seven (7) analytes: Ammonia, Acetaminophen, Alanine Aminotransferase (ALT), Hemoglobin A1c, Creatinine Kinase (CK), Cystatin C, and Salicylate.

    • Ongoing Z-1421-2020 FDA Class II initiated 12 Jan 2020

    Some lots ending in "17", "18", "19", or higher may have cuvette defects allowing water from the water bath to contaminate the interior of the cuvette, which may falsely elevate or depress sample results.

    • Terminated Z-1301-2019 FDA Class II initiated 7 Mar 2019

    There were multiple issues identified in the system software which required an update.

    • Terminated Z-0783-2019 FDA Class II initiated 26 Sep 2018 on shared 510(k) K161954

    Multiple Issues Identified in Atellica Solution System Software in V 1.14.2 and lower in: Atellica IM 1300 Analyzer Atellica IM 1600 Analyzer;Atellica CH 930 Analyzer; Atellica Sample Handler Prime

  • 3 recalls, same reason

    • Terminated Z-0190-2019 FDA Class II initiated 29 Jun 2018 on shared 510(k) K161954
    • Terminated Z-0189-2019 FDA Class II initiated 29 Jun 2018 on shared 510(k) K161954
    • Terminated Z-0191-2019 FDA Class II initiated 29 Jun 2018 on shared 510(k) K161954

    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.

    • Terminated Z-1587-2018 FDA Class II initiated 26 Feb 2018

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

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
JGS
Device Class
Class II
Regulation
21 CFR Part 862.1665
Advisory Committee
Clinical Chemistry
FDA Decision
SESE Substantially Equivalent

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