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ADVIA Centaur aTPO Assay, Material Number 10630886 (100… recallZ-3304-2024 · Siemens Healthcare Diagnostics, Inc. · initiated Aug 21, 2024

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Siemens Healthcare Diagnostics, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

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.

FDA root cause category: Under Investigation by firm

What the company is doing

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.

Recall details

Recall number
Z-3304-2024
Status
Open, Classified
Initiated by the company
Aug 21, 2024
Posted by the FDA
Sep 27, 2024
Recalling firm
Siemens Healthcare Diagnostics, Inc.
Quantity
5622 kits
Product code
JZO
FDA submissions
K003291
Distribution
Worldwide distribution - US Nationwide.

Product description

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

Code information (models, lots, serial numbers)

UDI-DI: Material Number 10630886 (100 Test) - 00630414587837; Material Number 10630887 (500 Test) - 00630414587844; Lot Number: 26053337 26054337 26051337 26052337

Devices named in this recall

2 devices in the FDA device registry whose identifier appears in the recall's code information.

Other devices under the same FDA submission

2 devices cleared under K003291 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 95259).

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page