—#114730

Product

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

FDA product code: MLM — Enzyme Immunoassay, Tracrolimus
Device class: Class 2
Medical specialty: Clinical Chemistry
510(k) numbers: K060502
Affected lot / code info: Lot numbers FA3085, exp 2013-03-26; and FA3316, exp 2013-11-12

Why it was recalled

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

Root cause (FDA determination)

Process control

Action the firm took

The firm initiated their recall of this product on November 27, 2012 by sending a letter to all consignees. The letter included a recall effectiveness check form to be completed by the consignee and returned to the firm. The firm expanded their recall on January 29, 2013 by sending another letter to consignees. This letter also included a recall effectiveness check form to be completed by the consignee and returned to the firm.

Recalling firm

Firm: Siemens Healthcare Diagnostics, Inc.
Address: 500 GBC Drive PO BOX 6101, Mailstop 514, Newark, Delaware 19714-6101

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2012-11-27
Posted by FDA: 2013-03-15
Terminated: 2014-08-04
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #114730. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.