Z-3304-2024Class II

ADVIA Centaur aTPO Assay, Material Number 10630886 (100 Test) and 10630887 (500 Test)

Name: Z-3304-2024 ADVIA Centaur aTPO Assay, Material Number 10630886 (100 Test) and 10630887 (500 Test)
Creator: Siemens Healthcare Diagnostics, Inc.
Published: 2024-08-21
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2024-08-21 / Open, Classified

FDA source

Siemens Healthcare Diagnostics, Inc. began a recall of ADVIA Centaur aTPO Assay, Material Number 10630886 (100 Test) and 10630887 (500 Test) on 2024-08-21. FDA classified it as Class II and gives the reason as "Positive bias in patient results at and below the cut-off of 60 U/mL with the lots listed in the table below when compared to alternate lots on the Atellica IM analyzer". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-3304-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-08-21
Posted: 2024-09-27
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: ADVIA Centaur aTPO Assay, Material Number 10630886 (100 Test) and 10630887 (500 Test)
Product code: JZO System, Test, Thyroid Autoantibody
Reason for recall: Positive bias in patient results at and below the cut-off of 60 U/mL with the lots listed in the table below when compared to alternate lots on the Atellica IM analyzer.
FDA root cause: Under Investigation by firm
Action: An Urgent Medical Device Correction notification letter dated 8/21/24 was sent to customers. Customer Actions " Please review this letter with your Medical Director to determine the appropriate course of action, including for any previously generated results, if applicable. " Perform the actions provided below: o Discontinue use of and discard the kit lots listed in the table above (Products Section). o You may request no-charge replacement product from your local Siemens Healthineers or distributor office. Please review your inventory of these products to determine your laboratory s replacement needs and to provide information to Siemens Healthineers for reporting to the authorities. o Complete and return the Field Correction Effectiveness Check and indicate product replacement needs on the form attached to this letter within 30 days. o Please retain this letter with your laboratory records and forward this letter to those who may have received this product. You may request no-charge replacement product from your local Siemens Healthineers or distributor office. Unaffected reagent lots are available for ordering. Please send a scanned copy of the completed form via email to: [email protected] Or to fax this completed form to the Customer Care Center at: (312) 275-7795 We apologize for the inconvenience this situation may cause. If you have any questions, please contact your Siemens Healthineers Customer Care Center or your local Siemens Healthineers technical support representative.
Quantity in commerce: 5622 kits
Distribution: Worldwide distribution - US Nationwide.
Product codes and lots: UDI-DI: Material Number 10630886 (100 Test) - 00630414587837; Material Number 10630887 (500 Test) - 00630414587844; Lot Number: 26053337 26054337 26051337 26052337

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-3304-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-3304-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-10-09	2024-09-27
Z-3305-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-10-09	2024-09-27

Product code JZO

K003291Class IIBayer Diagnostics Acs:180 and Advia Centaur Anti-Tpo AssayBayer Diagnostics Corp. / cleared 2000-12-05

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)