Aeroset System

• • Terminated Z-1671-2020 FDA Class II ·initiated 1 May 2019 ·via K980367, on the same 510(k)

  Mixer blade may separate from mixer due to the screw and nut failure and detachment. As a result of the mixer blade missing, the sample and reagent are inadequately mixed.

• • Terminated Z-1296-2019 FDA Class II ·initiated 28 Aug 2018

  There is a potential to generate falsely elevated serum or plasma chloride results when using the product.

• 3 recalls, same reason

  • Terminated Z-1104-2019 FDA Class II ·initiated 17 Jul 2018 ·via K980367, on the same 510(k)
  • Terminated Z-1103-2019 FDA Class II ·initiated 17 Jul 2018 ·via K980367, on the same 510(k)
  • Terminated Z-1102-2019 FDA Class II ·initiated 17 Jul 2018 ·via K980367, on the same 510(k)

  There is a potential to generate incorrect results on the instrument if particular error codes are not resolved before transitioning to the Running status.

• 3 recalls, same reason

  • Terminated Z-0921-2018 FDA Class II ·initiated 8 Dec 2017 ·via K980367, on the same 510(k)
  • Terminated Z-0922-2018 FDA Class II ·initiated 8 Dec 2017 ·via K980367, on the same 510(k)
  • Terminated Z-0923-2018 FDA Class II ·initiated 8 Dec 2017 ·via K980367, on the same 510(k)

  There is a potential to generate falsely depressed patient results in the cuvettes adjacent to the detached segment post for any assay run on the c4000, c8000, and c16000 instrument.

• 2 recalls, same reason

  • Completed Z-0165-2018 FDA Class II ·initiated 29 Sep 2017 ·via K980367, on the same 510(k)
  • Completed Z-0166-2018 FDA Class II ·initiated 29 Sep 2017 ·via K980367, on the same 510(k)

  The Peristaltic Head tubing placed on the ARCHITECT c4000, c8000, and c16000 has the possibility to leak due to a manufacturing issue associated with the tubing connector.

• • Terminated Z-0163-2016 FDA Class II ·initiated 9 Sep 2015 ·via K980367, on the same 510(k)

  Incorrect tubing.

• • Terminated Z-2202-2015 FDA Class II ·initiated 11 Jun 2015 ·via K980367, on the same 510(k)

  The ARCHITECT c8000 instrument contains tubing that does not meet specifications and has the potential to leak.

• • Terminated Z-1725-2015 FDA Class II ·initiated 11 May 2015 ·via K980367, on the same 510(k)

  The product is leaking from the cap and crystallization was noted as present around the cap.

• • Terminated Z-0011-2018 FDA Class II ·initiated 15 Jan 2015 ·via K980367, on the same 510(k)

  There is a potential to generate falsely-depressed patient results in the cuvettes adjacent to the detached segment post for any assay run on the c4000 instrument.

• • Terminated Z-1932-2015 FDA Class II ·initiated 22 Jul 2014 ·via K980367, on the same 510(k)

  ICT Serum Calibrator may generate lower than expected Potassium Quality Control (QC) and patient results on the Abbott Architect cSystem.

• • Terminated Z-2231-2008 FDA Unclassified (pre-2012) ·initiated 23 May 2008

  Software defect can allow tests ordered for one sample to be aspirated from a different sample, reporting erroneous results for the affected sample.

• • Terminated Z-1166-2008 FDA Unclassified (pre-2012) ·initiated 26 Sep 2007

  Quality Control (Out of Range)- ICT Calibrator lot number: 0505017, may contain an interferent. Not all vials within a kit are affected. The investigation determined that the interferent affects Potassium (K+) only. Use of the affected calibrator vials will generate an acceptable, but low calibration slope. When Quality Control (QC) is run to verify the calibration, K+ QC results may be bel

• • Terminated Z-0146-2008 FDA Unclassified (pre-2012) ·initiated 5 Sep 2007 ·via K980367, on the same 510(k)

  Incorrect Sample/Test Identification: Due to a software timing defect with certain versions of ARCHITECT cSystem Software, test results may be incorrectly associated to a Sample Identification during specific sample-processing conditions of the Robotic Sample Handler.

• • Terminated Z-0952-2007 FDA Unclassified (pre-2012) ·initiated 30 Apr 2007 ·via K980367, on the same 510(k)

  One or more of four software issues : 1) calculation error for Architect cSystem assays using the Spline math model. 2) The system configuration option, Run controls onboard reagents by Kit, does not function correctly for assays requiring a standard sample dilution. 3) Infrequent data may be missing from automatically or manually printed reports generated on the Architect system. 4) Clinical Chem

• • Terminated Z-0398-06 FDA Unclassified (pre-2012) ·initiated 8 Dec 2005 ·via K980367, on the same 510(k)

  System software assigns a calibrator default volume of 2.0uL when field is left empty by operator at time assay parameters set. Patient results could be affected if the volume required is not 2.0 uL.

• • Terminated Z-0010-06 FDA Unclassified (pre-2012) ·initiated 14 Sep 2005 ·via K980367, on the same 510(k)

  Software deficiency causing potential shift in absorbance readings for test results.

• • Terminated Z-0008-06 FDA Unclassified (pre-2012) ·initiated 28 Feb 2005 ·via K980367, on the same 510(k)

  Device has incorrect notation associated with therapeutic drug monitoring assays.

• • Terminated Z-0016-05 FDA Unclassified (pre-2012) ·initiated 24 Sep 2004 ·via K980367, on the same 510(k)

  Changes to the printer default settings made by users/operators cause printed data to be truncated and misidentified.

• • Terminated Z-1341-04 FDA Unclassified (pre-2012) ·initiated 10 Jun 2004

  Process change in the manufacturing of the AC/DC driver board used on the analyzer may result in one or more of the solid state relays to fail during use.

• • Terminated Z-0846-04 FDA Unclassified (pre-2012) ·initiated 22 Mar 2004 ·via K980367, on the same 510(k)

  Change of level 3 error log messages to level 1 to prevent suspect assay results.

• • Terminated Z-0818-04 FDA Unclassified (pre-2012) ·initiated 19 Mar 2004 ·via K980367, on the same 510(k)

  When using a LIS the software system will send up a test result of up to 20 characters although the field is set to display only 15 characters per the RS-232 Manual.

• • Terminated Z-0263-04 FDA Unclassified (pre-2012) ·initiated 17 Nov 2003 ·via K980367, on the same 510(k)

  Sample Identification (SID) numbers of a bar coded sample may be truncated, or shortened, after being scanned by the bar code reader (e.g. an actual SID of 123456 is shortened to 1234)

• • Terminated Z-0091-04 FDA Unclassified (pre-2012) ·initiated 30 Sep 2003 ·via K980367, on the same 510(k)

  Audible alarm occurs before aspiration potentially resulting in operator injury or results assigned to wrong patient for STAT samples.

• • Terminated Z-0788-03 FDA Unclassified (pre-2012) ·initiated 24 Feb 2003 ·via K980367, on the same 510(k)

  Software failure to detect error in reference solution set-up can cause inaccurate results for Sodium, Potassium, and Chloride.

• • Terminated Z-0725-03 FDA Unclassified (pre-2012) ·initiated 24 Feb 2003 ·via K980367, on the same 510(k)

  Under certain operating conditions, smart wash feature disables with multiple samples.

• • Terminated Z-0796-03 FDA Unclassified (pre-2012) ·initiated 27 Jan 2003 ·via K980367, on the same 510(k)

  External waste pump has metal edge around perimeter sharp enough to cause scratch or cut.

• • Terminated Z-0844-03 FDA Unclassified (pre-2012) ·initiated 15 Aug 2002 ·via K980367, on the same 510(k)

  Design of high concentration waste line causes formation of a precipitate in the waste line causing overflow of waste.

• • Terminated Z-0843-03 FDA Unclassified (pre-2012) ·initiated 2 Oct 2001 ·via K980367, on the same 510(k)

  Extensive use of cuvettes causes inaccurate results. Preventative maintenance did not specify replacement schedule.

• • Terminated Z-1142-03 FDA Unclassified (pre-2012) ·initiated 29 Dec 2000 ·via K980367, on the same 510(k)

  ICT assays run using a manual dilution will not be calculated correctly by the software.

Recalls marked "via" name another device cleared under the same FDA submission as this one.

510(k) Number

K980367 ↗

FDA Product Code

CGZ

Device Class

Class II

Regulation

21 CFR Part 862.1170

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

• Architect 01G06-01

  Class I

  GUDID on market

• Architect 03M7401

  Class I

  GUDID on market

• Alinity 06P0107

  Not classified

  GUDID on market

• Alinity 06P0161

  Not classified

  GUDID on market

• Alinity 06P0115

  Not classified

  GUDID on market

• Alinity 06P0125

  Not classified

  GUDID on market

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