FDA Medical Device Recalls (openFDA)
Siemens Healthcare Diagnostics, Inc.: Siemens Dimension(R) Tacrolimus Flex(R) reagent cartridge (DF107). The TACR method is used as an in vitro diagnostic test.
- Recall number
- Z-0957-2013
- Recalling firm
- Siemens Healthcare Diagnostics, Inc.
- Product
- Siemens Dimension(R) Tacrolimus Flex(R) reagent cartridge (DF107). The TACR method is used as an in vitro diagnostic test.
- Status
- Terminated
- Initiated
- 2012-11-27
- Posted
- 2013-03-15
- Terminated
- 2014-08-04
- 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.
- Lot, serial or model codes
- Lot numbers FA3085, exp 2013-03-26; and FA3316, exp 2013-11-12
- 510(k) numbers
- ["K060502"]
- PMA numbers
- not on file
- Product code
- MLM
- Firm FEI
- 2517506
- Firm city
- Newark
- Firm state
- DE
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28