Skip to content

Abbott Architect Testosterone

by Abbott Laboratories 510(k)

Active United States

510(k) K983212

Regulatory status

as of 26 Oct 2026

Recall ongoing on a related submission. 2 ongoing FDA recalls. See recalls

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK983212 Date18 Nov 1998ClearedStatusActive

Coverage

1 jurisdiction

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

United States — FDA 510(k) Active

Recalls

14 recalls · 2 ongoing · FDA

  • 2 recalls, same reason

    • Ongoing Z-0272-2022 FDA Class II initiated 29 Sep 2021 via K983212, on the same 510(k)
    • Ongoing Z-0271-2022 FDA Class II initiated 29 Sep 2021 via K983212, on the same 510(k)

    Twelve software-related issues affecting software version 9.41 and earlier were identified. The issues include bypassing error codes, incorrect calibration, loss of module communication leading to overfilling wash buffer containers, missing QC flags, signal spikes, abnormal optics reads, and incorrect sample aspiration. The issues may lead to inaccurate results with an unknown bias direction and magnitude for assays measuring cardiac, metabolic (including diabetes), toxicology, prenatal, therapeutic drug monitoring, infectious disease, oncology, hepatic, pancreatic, hematological, endocrinologic, inflammatory analytes.

    • Terminated Z-1316-2010 FDA Unclassified (pre-2012) initiated 11 Sep 2009 via K983212, on the same 510(k)

    ARCHITECT System Software v5.00 and v5.10 are incompatible with ARCHITECT LLS Board. Software patch re-establishes correct parameters.

    • Terminated Z-0132-2010 FDA Unclassified (pre-2012) initiated 17 Jul 2009 via K983212, on the same 510(k)

    Under certain conditions, the product's wash buffer containing sodium azide can come in contact with the wash zone mechanism ground cables on either of the two wash zones. The copper in the ground strap may corrode and form an unstable chemical substance (metal azide) that may be sensitive to direct pressure and impact.

  • 2 recalls, same reason

    • Terminated Z-0951-2007 FDA Unclassified (pre-2012) initiated 30 Apr 2007 via K983212, on the same 510(k)
    • Terminated Z-0950-2007 FDA Unclassified (pre-2012) initiated 30 Apr 2007 via K983212, 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

  • 2 recalls, same reason

    • Terminated Z-0791-2007 FDA Unclassified (pre-2012) initiated 28 Mar 2007 via K983212, on the same 510(k)
    • Terminated Z-0790-2007 FDA Unclassified (pre-2012) initiated 28 Mar 2007 via K983212, on the same 510(k)

    If the ARCHITECT i2000/i2000sr System becomes contaminated with microbes generating folate-like by-products, the ARCHITECT Folate assay may experience calibration failures and/or shifts in results.

  • 2 recalls, same reason

    • Terminated Z-0415-2007 FDA Unclassified (pre-2012) initiated 12 Dec 2006 via K983212, on the same 510(k)
    • Terminated Z-0416-2007 FDA Unclassified (pre-2012) initiated 12 Dec 2006 via K983212, on the same 510(k)

    The re-designed ARCHITECT Temperature Controller Board has been identified as being susceptible to electromagnetic interference (EMI) in the laboratory. This can cause a board reset condition, stopping temperature control function of the board. Situation does not stop analyzer operation and does not generate an error condition alerting operator when condition occurs.

    • Terminated Z-0818-04 FDA Unclassified (pre-2012) initiated 19 Mar 2004 via K983212, 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-0262-04 FDA Unclassified (pre-2012) initiated 17 Nov 2003 via K983212, 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-0172-04 FDA Unclassified (pre-2012) initiated 8 May 2002 via K983212, on the same 510(k)

    If the interlock cable connected to the door lid sensor is disconnected or fails, the lid is detected as closed even though it may be open.

    • Terminated Z-1133-03 FDA Unclassified (pre-2012) initiated 10 Dec 2001 via K983212, on the same 510(k)

    Under specific conditions, the system can allow an incorrect sample ID to be assigned to another sample in a different carrier.

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

Specification

510(k)

510(k) Number
FDA Product Code
CDZ
Device Class
Class I
Regulation
21 CFR Part 862.1680
Advisory Committee
Clinical Chemistry
FDA Decision
SESE Substantially Equivalent

Other devices from Abbott Laboratories

See all devices from Abbott Laboratories →