Recall Z-0957-2013
Siemens Healthcare Diagnostics, Inc. · initiated November 27, 2012
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Siemens Dimension(R) Tacrolimus Flex(R) reagent cartridge (DF107). The TACR method is used as an in vitro diagnostic test.
Codes / lots: Lot numbers FA3085, exp 2013-03-26; and FA3316, exp 2013-11-12
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
FDA-determined cause: Process control
Action taken
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.
Details
- Recall number
- Z-0957-2013
- Initiated
- November 27, 2012
- Posted by FDA
- March 15, 2013
- Terminated
- August 4, 2014
- Product code
- MLM – Enzyme Immunoassay, Tracrolimus
- 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.
- Recalling firm
- Siemens Healthcare Diagnostics, Inc., Newark, DE