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ADVIA Chemistry Iron_2 (IRON_2) Reagents, Material Numbers… recallZ-2666-2023 · Siemens Healthcare Diagnostics, Inc. · initiated Aug 8, 2023

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

There is a potential for a positive bias on Quality Control (QC) and patient sample results when using some IRON_2 reagent wedge pairs. When the issue occurs, the observed bias will vary wedge to wedge.

FDA root cause category: Under Investigation by firm

What the company is doing

An Urgent Medical Device Correction notification letter dated 8/8/23 was sent to customers. Actions to be Taken by the Customer 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 in Additional Information. Complete and return the Field Correction Effectiveness Check Form attached to this letter within 30 days. If you have received any complaints of illness or adverse events associated with the products listed in Table 1, immediately contact your local Siemens Healthineers Customer Care Center or your local Siemens Healthineers technical support representative. Please retain this letter with your laboratory records and forward this letter to those who may have received this product. 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. Additional Information Please complete these instructions with each wedge set in your inventory prior to processing patient samples. 1. Ensure only one R1 and one R2 is onboard the system. 2. Run each level of QC that your laboratory has identified for use with IRON_2 on that reagent wedge set and determine if your QC criteria are met. 3. If acceptance criteria IS met, proceed using the R1/R2 wedge to generate patient results. 4. If the acceptance criteria IS NOT met, discard the reagent wedge set. If you have another set of IRON_2 reagent, repeat steps 1 3 and assess acceptance.

Recall details

Recall number
Z-2666-2023
Status
Open, Classified
Initiated by the company
Aug 8, 2023
Posted by the FDA
Sep 30, 2023
Recalling firm
Siemens Healthcare Diagnostics, Inc.
Quantity
4966 reagents
Product code
CDQ
Distribution
US Nationwide. Global Distribution

Product description

ADVIA Chemistry Iron_2 (IRON_2) Reagents, Material Numbers 10377510 (6 x 350 tests) and 10341118 (7 x 145 tests)

Code information (models, lots, serial numbers)

(6 x 350 tests) UDI-DI: 00630414561974; (7 x 145 tests) UDI-DI: 00630414513157; Lot Numbers: 612584 625096 612579 625091 635826 635821

Devices named in this recall

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

Sources and updates

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