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

FDA Recall #Z-2666-2023 — Class II — August 8, 2023

Recall #Z-2666-2023 Date: August 8, 2023 Classification: Class II Status: Ongoing

Product Description

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

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.

Recalling Firm

Siemens Healthcare Diagnostics, Inc. — Tarrytown, NY

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Devices

Product Quantity

4966 reagents

Distribution

US Nationwide. Global Distribution

Code Information

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

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.

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