Z-2666-2023Class II

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

Name: Z-2666-2023 ADVIA Chemistry Iron_2 (IRON_2) Reagents, Material Numbers 10377510 (6 x 350 tests) and 10341118 (7 x 145...
Creator: Siemens Healthcare Diagnostics, Inc.
Published: 2023-08-08
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2023-08-08 / Open, Classified

FDA source

Siemens Healthcare Diagnostics, Inc. began a recall of ADVIA Chemistry Iron_2 (IRON_2) Reagents, Material Numbers 10377510 (6 x 350 tests) and 10341118 (7 x 145 tests) on 2023-08-08. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-2666-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-08-08
Posted: 2023-09-30
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: ADVIA Chemistry Iron_2 (IRON_2) Reagents, Material Numbers 10377510 (6 x 350 tests) and 10341118 (7 x 145 tests)
Product code: CDQ Urease And Glutamic Dehydrogenase, Urea Nitrogen
Reason for recall: 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: Under Investigation by firm
Action: 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.
Quantity in commerce: 4966 reagents
Distribution: US Nationwide. Global Distribution
Product codes and lots: (6 x 350 tests) UDI-DI: 00630414561974; (7 x 145 tests) UDI-DI: 00630414513157; Lot Numbers: 612584 625096 612579 625091 635826 635821

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2666-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2666-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-10-11	2023-09-29

Product code CDQ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)