Advia Centaur and Acs: 180 Folate Immunoassay

• 3 recalls, same reason

  • Ongoing Z-1152-2023 FDA Class II ·initiated 9 Jan 2023 ·on shared 510(k) K010050
  • Ongoing Z-1154-2023 FDA Class II ·initiated 9 Jan 2023 ·on shared 510(k) K010050
  • Ongoing Z-1153-2023 FDA Class II ·initiated 9 Jan 2023 ·on shared 510(k) K010050

  Negative bias occurred when whole blood calibration (Atellica IM Fol or ADVIA Centaur FolateBA/FolBA) used to test serum samples.

• 3 recalls, same reason

  • Terminated Z-0829-2020 FDA Class II ·initiated 22 Jul 2019
  • Terminated Z-0831-2020 FDA Class II ·initiated 22 Jul 2019
  • Terminated Z-0830-2020 FDA Class II ·initiated 22 Jul 2019

  Homocysteine Assay May Cause Elevated Results in the Folate Assay

• • Terminated Z-1689-2018 FDA Class II ·initiated 2 Jan 2018

  Concentrations for the level of biotin that does not interfere is not currently listed in the instruction for use for the Dimension Vista CTNI, Dimension Vista MMB, Dimension Sirolimus, ADVIA Centaur FOL, ADVIA Centaur aHBcM and the following IMMULITE assays, 3gAllergy Specific IgE, anti-HBc, BR-MA (CA15-3), CEA, Folic Acid, Gastrin, OM-MA (CA125), Thyroglobulin, and Vitamin B12, and these assays are susceptible to interference from biotin.

• • Terminated Z-2739-2015 FDA Class II ·initiated 27 Jul 2015

  Low red blood cell control recoveries and low results for red blood cell patient samples when using the ADVIA Centaur Systems Folate assay.

• • Terminated Z-1564-2014 FDA Class II ·initiated 25 Mar 2014

  Serum controls may go out of range low with the ADVIA Centaur Systems Folate assay and a shift in whole blood patient may result with kit lots ending in 219 and 223

• 4 recalls, same reason

  • Terminated Z-2172-2013 FDA Class II ·initiated 25 Jul 2013
  • Terminated Z-2170-2013 FDA Class II ·initiated 25 Jul 2013
  • Terminated Z-2171-2013 FDA Class II ·initiated 25 Jul 2013
  • Terminated Z-2169-2013 FDA Class II ·initiated 25 Jul 2013

  Calibration failures and/or significant negative shifts in quality control (QC) and patient results.

• • Terminated Z-0511-2013 FDA Class II ·initiated 14 Nov 2012

  Operating range of the ADVIA Centaur systems is 18C to 30C (64.4F to 86.0F), a change in room temperature may increase or decrease assay results, depending on the specific assay and ADVIA Centaur system used.

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

510(k) Number

K010050 ↗

FDA Product Code

CGN

Device Class

Class II

Regulation

21 CFR Part 862.1295

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

• Salicylate Assay for the Advia Integrated Modular System

  Class II

  FDA 510(k) K020794 Active Cleared 11 Jul 2002

• Bayer Special Chemistry Controls

  Class I

  FDA 510(k) K033379 Active Cleared 19 Dec 2003

• Ammonia Assay for the Advia 1650

  Class I

  FDA 510(k) K023841 Active Cleared 24 Dec 2002

• Uric Acid Assay for the Advia Integrated Modular System

  Class I

  FDA 510(k) K022096 Active Cleared 18 Mar 2003

• Bayer Special Chemistry Calibrators

  Class II

  FDA 510(k) K033380 Active Cleared 16 Dec 2003

• Ca 15-3 Assay for the Advia Integrated Modular System

  Class II

  FDA 510(k) K022178 Active Cleared 12 Nov 2002

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