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U.S. Department of Health and Human Services

Class 2 Device Recall ADVIA Chemistry Iron_2 (IRON_2) Reagents

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 Class 2 Device Recall ADVIA Chemistry Iron_2 (IRON_2) Reagentssee related information
Date Initiated by FirmAugust 08, 2023
Date PostedSeptember 30, 2023
Recall Status1 Open3, Classified
Recall NumberZ-2666-2023
Recall Event ID 92971
Product Classification Urease and glutamic dehydrogenase, urea nitrogen - Product Code CDQ
ProductADVIA Chemistry Iron_2 (IRON_2) Reagents, Material Numbers 10377510 (6 x 350 tests) and 10341118 (7 x 145 tests)
Code Information (6 x 350 tests) UDI-DI: 00630414561974; (7 x 145 tests) UDI-DI: 00630414513157; Lot Numbers: 612584 625096 612579 625091 635826 635821
Recalling Firm/
Manufacturer		 Siemens Healthcare Diagnostics, Inc.
511 Benedict Ave
Tarrytown NY 10591-5005
For Additional Information Contact
914-631-8000
Manufacturer 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 Determined
Cause 2		Under Investigation by firm
ActionAn 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 Commerce4966 reagents
DistributionUS Nationwide. Global Distribution
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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