Trinidad IM Thyroid Stimulating Hormone (TSH) Assay, Trinidad IM TSH Calibrators, Trinidad Immunoassay (IM) System

• 2 recalls, same reason

  • Ongoing Z-1252-2022 FDA Class II ·initiated 13 Apr 2022
  • Ongoing Z-1253-2022 FDA Class II ·initiated 13 Apr 2022

  Lots incompatible with Test Definition (TDef) Version 1.4, potentially lead to the generation of erroneous total T3 results

• 2 recalls, same reason

  • Ongoing Z-0125-2022 FDA Class II ·initiated 28 Sep 2021 ·on shared 510(k) K151792
  • Ongoing Z-0124-2022 FDA Class II ·initiated 28 Sep 2021 ·on shared 510(k) K151792

  Ancillary reagent packs used on Atellica IM 1300 and Atellica IM 1600 analyzers may overflow when pierced while on an analyzer located at an altitude of greater than 350m (1148ft) above sea level. As a result, customers at these altitudes may observe an increased number of Reagent Volume Check Errors.

• 2 recalls, same reason

  • Ongoing Z-2027-2021 FDA Class II ·initiated 13 May 2021
  • Ongoing Z-2028-2021 FDA Class II ·initiated 13 May 2021

  Valves used on the Atellica CH 930, Atellica IM 1300 and Atellica IM 1600 analyzers may develop a malfunction due to a manufacturing defect and may result in the valve wearing and leaking over time. The leaking is a risk in valves subject to high pressure or high wear and may impact the result accuracy of any assay.

• • Ongoing Z-2404-2020 FDA Class II ·initiated 7 May 2020 ·on shared 510(k) K151792

  Insufficient sample may not be detected when using Tube Top Sample Cup (TTSC) or V-shaped Sample Cup sample containers with the Atellica IM1300 and IM1600 analyzers.

• • Ongoing Z-2405-2020 FDA Class II ·initiated 7 May 2020 ·on shared 510(k) K151792

  Insufficient sample may not be detected when using Tube Top Sample Cup (TTSC) or V-shaped Sample Cup sample containers with the Atellica IM1300 and Atellica IM1600 analyzers.

• 2 recalls, same reason

  • Terminated Z-0863-2021 FDA Class II ·initiated 2 Dec 2020 ·on shared 510(k) K151792
  • Terminated Z-0862-2021 FDA Class II ·initiated 2 Dec 2020 ·on shared 510(k) K151792

  Multiple issues in Software v1.23.2 and lower-may lead to the reporting of discrepant patient results

• • Terminated Z-0474-2021 FDA Class II ·initiated 26 Oct 2020

  Test Definition scanning may reset custom settings to defaults. When a 2D Master Curve and TDef barcode for a new kit lot of reagent is scanned and the TDef version is a newer version than the version that is currently on the system, some of the customer defined settings for that assay may reset to default values

• • Terminated Z-0473-2021 FDA Class II ·initiated 26 Oct 2020

  Test Definition scanning may reset custom settings to defaults causing falsely low or high results. When a 2D Master Curve and TDef barcode for a new kit lot of reagent is scanned and the TDef version is a newer version than the version that is currently on the system, some of the customer defined settings for that assay may reset to default values

• 2 recalls, same reason

  • Terminated Z-0204-2020 FDA Class II ·initiated 15 Aug 2019 ·on shared 510(k) K151792
  • Terminated Z-0205-2020 FDA Class II ·initiated 15 Aug 2019 ·on shared 510(k) K151792

  Issues Scanning New Reagent Lot Test Definition on the Atellica IM 1300 Analyzer and Atellica IM 1600 Analyzer SW V 1.19.0 and 1.19.2

• 2 recalls, same reason

  • Terminated Z-1300-2019 FDA Class II ·initiated 7 Mar 2019
  • Terminated Z-1299-2019 FDA Class II ·initiated 7 Mar 2019

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

• 2 recalls, same reason

  • Terminated Z-0781-2019 FDA Class II ·initiated 26 Sep 2018 ·on shared 510(k) K151792
  • Terminated Z-0780-2019 FDA Class II ·initiated 26 Sep 2018 ·on shared 510(k) K151792

  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

• 2 recalls, same reason

  • Terminated Z-0192-2019 FDA Class II ·initiated 29 Jun 2018 ·on shared 510(k) K151792
  • Terminated Z-0193-2019 FDA Class II ·initiated 29 Jun 2018 ·on shared 510(k) K151792

  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.

• 2 recalls, same reason

  • Terminated Z-1586-2018 FDA Class II ·initiated 26 Feb 2018 ·on shared 510(k) K151792
  • Terminated Z-1588-2018 FDA Class II ·initiated 26 Feb 2018 ·on shared 510(k) K151792

  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.

510(k) Number

K151792 ↗

FDA Product Code

JLW

Device Class

Class II

Regulation

21 CFR Part 862.1690

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

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  Class II

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