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ADVIA Centaur CA 19-9 recallZ-3104-2024 · Siemens Healthcare Diagnostics, Inc. · initiated Jul 26, 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 for some samples around the CA 19-9 upper limit of normal of 35 U/m as compared to the previous lot. The sample bias observed was greatest in the Asia Pacific sample population. The observed bias is not proportional across the assay measuring interval and is less pronounced for sample results above a concentration of 110 U/mL.

FDA root cause category: Under Investigation by firm

What the company is doing

Siemens has issued an Urgent Medical Device Correction (UMDC) AIMC 24-14.A.US to US customers, and an Urgent Field Safety Notice (UFSN) AIMC 24-14.A.OUS to Outside the US (OUS) customers on 7/26/24. Letter states reason for recall, health risk and action to take: " 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 instructions provided below: o Discontinue use of and discard the kit lots listed in the table above (Products Section). o If you experience this issue, 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. Resolution CA 19-9 kit lots ending in 535 are not available for purchase or use. You may request no-charge replacement product from your local Siemens Healthineers or distributor office. 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-3104-2024
Status
Open, Classified
Initiated by the company
Jul 26, 2024
Posted by the FDA
Sep 11, 2024
Recalling firm
Siemens Healthcare Diagnostics, Inc.
Product code
NIG
FDA submissions
K031393
Distribution
Worldwide - US Nationwide distribution

Product description

ADVIA Centaur CA 19-9 (250 Test)-In vitro diagnostic use in the quantitative measurement of the CA 19-9 tumor-associated antigen in human serum using the Atellica CI and Atellica IM Analyzers SMN: 10491244

Code information (models, lots, serial numbers)

UDI-DI: (01)00630414574028(10)55972535(17)20240914; (01)00630414574028(10)55973535(17)20240914 Kit Lot: 55972535, 55973535

Devices named in this recall

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

Product lines

Other devices under the same FDA submission

4 devices cleared under K031393 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 95118).

Sources and updates

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