—#209834

Product

Atellica IM aTPO Assay, Material Number 10995466 (100 Test) and 10995467 (500 Test)

FDA product code: JZO — System, Test, Thyroid Autoantibody
Device class: Class 2
Medical specialty: Immunology
510(k) numbers: K003291
Affected lot / code info: UDI-DI: Material Number 10995466 (100 Test) - 00630414597935; Material Number 10995467 (500 Test) - 00630414597942; Lot Number: 26098336 26099336

Why it was recalled

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 (FDA determination)

Under Investigation by firm

Action the firm took

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.

Recalling firm

Firm: Siemens Healthcare Diagnostics, Inc.
Address: 511 Benedict Ave, Tarrytown, New York 10591-5005

Distribution

Distribution pattern: Worldwide distribution - US Nationwide.

Timeline

Recall initiated: 2024-08-21
Posted by FDA: 2024-09-27
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #209834. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.