Recall Z-0957-2013 ยท MLM Enzyme Immunoassay, Tracrolimus
Siemens Healthcare Diagnostics, Inc.
Siemens Dimension(R) Tacrolimus Flex(R) reagent cartridge (DF107). The TACR method is used as an in vitro diagnostic test.
| Date | Mar 15, 2013 (initiated Nov 27, 2012) |
| Status | Terminated |
| Reason | 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 | Process control |
| Action | 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. |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K060502 | DIMENSION TACR FLEX REAGENT CARTRIDGE, MODEL DF107 Dade Behring, Inc., May 18, 2006 |