# K980367: Aeroset System

- Pathway: 510(k) (Traditional)
- Applicant: Abbott Laboratories
- Decided: Apr 1, 1998 after 62 days
- Product code: CGZ (Electrode, Ion-Specific, Chloride)
- Device class: 2
- Regulation: 21 CFR 862.1170
- Recalls of this device: 34 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K872494 (1987). 1 ancestor in all.
7 later devices descend from it; 3 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K872494: Hitachi 717 Chemistry Analyzer, Boehringer Mannheim Corp. (1987) Summary page 3.

## Most influential descendants
- K093318: Accelerator Aps (2010), 3 descendants of its own
- K213486: GLP systems Track (2022), 1 descendant of its own
- K170320: Alinity c ICT Sample Diluent (2017), 1 descendant of its own
- K170316: Alinity C Glucose Reagent Kit, Alinity C System (2017), 1 descendant of its own
- K230937: Alinity i Total ß-hCG Reagent Kit, GLP systems Track (2023), 0 descendants of its own

## Recalls of this device
- May 1, 2019 · Class II · Z-1671-2020: 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.
- Aug 28, 2018 · Class II · Z-1296-2019: There is a potential to generate falsely elevated serum or plasma chloride results when using the product.
- Jul 17, 2018 · Class II · Z-1102-2019: There is a potential to generate incorrect results on the instrument if particular error codes are not resolved before transitioning to the Running status.
- Jul 17, 2018 · Class II · Z-1104-2019: There is a potential to generate incorrect results on the instrument if particular error codes are not resolved before transitioning to the Running status.
- Jul 17, 2018 · Class II · Z-1103-2019: There is a potential to generate incorrect results on the instrument if particular error codes are not resolved before transitioning to the Running status.
- Dec 8, 2017 · Class II · Z-0922-2018: 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.
- Dec 8, 2017 · Class II · Z-0921-2018: 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.
- Dec 8, 2017 · Class II · Z-0923-2018: 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.
- Sep 29, 2017 · Class II · Z-0165-2018: 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.
- Sep 29, 2017 · Class II · Z-0166-2018: 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.
- Sep 9, 2015 · Class II · Z-0163-2016: Incorrect tubing.
- Jun 11, 2015 · Class II · Z-2202-2015: The ARCHITECT c8000 instrument contains tubing that does not meet specifications and has the potential to leak.
- May 11, 2015 · Class II · Z-1725-2015: The product is leaking from the cap and crystallization was noted as present around the cap.
- Jan 15, 2015 · Class II · Z-0011-2018: 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.
- Jul 22, 2014 · Class II · Z-1932-2015: ICT Serum Calibrator may generate lower than expected Potassium Quality Control (QC) and patient results on the Abbott Architect cSystem.
- May 23, 2008 · Not classified · Z-2231-2008: Software defect can allow tests ordered for one sample to be aspirated from a different sample, reporting erroneous results for the affected sample.
- Sep 26, 2007 · Not classified · Z-1166-2008: 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 Potas
- Sep 5, 2007 · Not classified · Z-0146-2008: 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 
- Apr 30, 2007 · Not classified · Z-0952-2007: 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 
- Dec 8, 2005 · Not classified · Z-0398-06: 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.
- Sep 14, 2005 · Not classified · Z-0010-06: Software deficiency causing potential shift in absorbance readings for test results.
- Feb 28, 2005 · Not classified · Z-0008-06: Device has incorrect notation associated with therapeutic drug monitoring assays.
- Sep 24, 2004 · Not classified · Z-0016-05: Changes to the printer default settings made by users/operators cause printed data to be truncated and misidentified.
- Jun 10, 2004 · Not classified · Z-1341-04: 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.
- Mar 22, 2004 · Not classified · Z-0846-04: Change of level 3 error log messages to level 1 to prevent suspect assay results.
- Mar 19, 2004 · Not classified · Z-0818-04: 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.
- Nov 17, 2003 · Not classified · Z-0263-04: 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)
- Sep 30, 2003 · Not classified · Z-0091-04: Audible alarm occurs before aspiration potentially resulting in operator injury or results assigned to wrong patient for STAT samples.
- Feb 24, 2003 · Not classified · Z-0725-03: Under certain operating conditions, smart wash feature disables with multiple samples.
- Feb 24, 2003 · Not classified · Z-0788-03: Software failure to detect error in reference solution set-up can cause inaccurate results for Sodium, Potassium, and Chloride.
- Jan 27, 2003 · Not classified · Z-0796-03: External waste pump has metal edge around perimeter sharp enough to cause scratch or cut.
- Aug 15, 2002 · Not classified · Z-0844-03: Design of high concentration waste line causes formation of a precipitate in the waste line causing overflow of waste.
- Oct 2, 2001 · Not classified · Z-0843-03: Extensive use of cuvettes causes inaccurate results. Preventative maintenance did not specify replacement schedule.
- Dec 29, 2000 · Not classified · Z-1142-03: ICT assays run using a manual dilution will not be calculated correctly by the software.

## Indications for use
Per 21 CFR 862.2160, the AEROSET System is a discrete photometric chemistry Analyzer for clinical use. The device is intended to duplicate manual analytical procedures by performing various steps such as pipetting, heating, and measuring color intensity. This device is intended for use in conjunction with certain materials to measure a variety of analytes. The AEROSET System also has a solid state Ion-Selective Electrode module, trademarked as Integrated Chip Technology™ (ICT), utilizing potentiometry, for electrolyte determinations (sodium, potassium, and chloride).

Source page: https://510kreport.com/device/K980367
Methodology: https://510kreport.com/methodology