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Siemens Dimension(R) Tacrolimus Flex(R) reagent cartridge (DF107). The TACR method is used as an ...

FDA Recall #Z-0957-2013 — Class II — November 27, 2012

Recall #Z-0957-2013 Date: November 27, 2012 Classification: Class II Status: Terminated

Product Description

Siemens Dimension(R) Tacrolimus Flex(R) reagent cartridge (DF107). The TACR method is used as an in vitro diagnostic test.

Reason for Recall

Siemens has confirmed customer complaints of low patient sample recovery with Dimension(R) TACR Flex(R) lot FA3085. Quality Control (QC) materials have not exhibited low recovery of the same magnitude. Internal method regression testing versus LC/MS has shown an average 25% low bias compared to LC/MS across the assay range. Individual patients, particularly samples with lower TACR values

Recalling Firm

Siemens Healthcare Diagnostics, Inc. — Newark, DE

Classification

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

Product Type

Devices

Product Quantity

2,976

Distribution

Product was distributed within the United States to AL, AZ, CA, DC, FL, LA, MD, MI, MO, NJ, NM, NC, OH, OR, PA, TN, TX, UT, VA, and WA.

Code Information

Lot numbers FA3085, exp 2013-03-26; and FA3316, exp 2013-11-12

Status

Terminated

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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