FDA Medical Device Recalls (openFDA)
Siemens Healthcare Diagnostics, Inc.: ADVIA Centaur aTPO Assay, Material Number 10630886 (100 Test) and 10630887 (500 Test)
- Recall number
- Z-3304-2024
- Recalling firm
- Siemens Healthcare Diagnostics, Inc.
- Product
- ADVIA Centaur aTPO Assay, Material Number 10630886 (100 Test) and 10630887 (500 Test)
- Status
- Open, Classified
- Initiated
- 2024-08-21
- Posted
- 2024-09-27
- Terminated
- not on file
- Reason
- 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.
- 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: uscctsfcaecfax.team@siemens-healthineers.com 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
- 5622 kits
- Distribution
- Worldwide distribution - US Nationwide.
- Lot, serial or model codes
- UDI-DI: Material Number 10630886 (100 Test) - 00630414587837; Material Number 10630887 (500 Test) - 00630414587844; Lot Number: 26053337 26054337 26051337 26052337
- 510(k) numbers
- ["K003291"]
- PMA numbers
- not on file
- Product code
- JZO
- Firm FEI
- 2432235
- Firm city
- Tarrytown
- Firm state
- NY
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28