Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Siemens Healthcare ADVIA Centaur Folate (FOL) 500 Test 06891541 100 Recalled by Siemens Healthcare Diagnostics, Inc Due to Operating range of the ADVIA Centaur systems is...

Date: November 14, 2012
Company: Siemens Healthcare Diagnostics, Inc
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Siemens Healthcare Diagnostics, Inc directly.

Affected Products

Siemens Healthcare ADVIA Centaur Folate (FOL) 500 Test 06891541 100 Test 06367974 Ref Kit (US only) 09132781 Ref Kit (US only) 00203473 Intended Use For in vitro diagnostic use in the quantitative determination of folate in serum or red blood cells using the ADVIA Centaur and ADVIA Centaur XP systems.

Quantity: 100 Test=27392; 500 test=21045 and Reference Kits=3773

Why Was This Recalled?

Operating range of the ADVIA Centaur systems is 18C¿ to 30¿C (64.4¿F to 86.0¿F), a change in room temperature may increase or decrease assay results, depending on the specific assay and ADVIA Centaur system used.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Siemens Healthcare Diagnostics, Inc

Siemens Healthcare Diagnostics, Inc has 118 total recalls tracked by RecallDetector.

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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report