Recall Z-0957-2013— Siemens Healthcare Diagnostics, Inc.
Class II · Terminated
Class II FDA medical device recall by Siemens Healthcare Diagnostics, Inc., initiated 2012-11-27, terminated 2014-08-04. It names one FDA 510(k) clearance: K060502. Product: Siemens Dimension(R) Tacrolimus Flex(R) reagent cartridge (DF107). The TACR method is used as an in vitro diagnostic test.. 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.
- Recalling firm
- Siemens Healthcare Diagnostics, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2012-11-27
- Terminated
- 2014-08-04
- Firm location
- Newark, DE, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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
Data sourced from openFDA. This site is unofficial and independent of the FDA.