—#203043

Product

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

FDA product code: CDQ — Urease And Glutamic Dehydrogenase, Urea Nitrogen
Device class: Class 2
Medical specialty: Clinical Chemistry
Affected lot / code info: (6 x 350 tests) UDI-DI: 00630414561974; (7 x 145 tests) UDI-DI: 00630414513157; Lot Numbers: 612584 625096 612579 625091 635826 635821

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.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

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.

Recalling firm

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

Distribution

Distribution pattern: US Nationwide. Global Distribution

Timeline

Recall initiated: 2023-08-08
Posted by FDA: 2023-09-30
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #203043. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.