Recall Z-1633-2016— Siemens Healthcare Diagnostics, Inc.
Class II · Terminated
Class II FDA medical device recall by Siemens Healthcare Diagnostics, Inc., initiated 2016-02-09, terminated 2018-06-12. It names one FDA 510(k) clearance: K081857. Product: Dimension clinical chemistry system, Sirolimus (SIRO) Flex reagent cartridge (DF306 SMN 10464331) Lot EB6064, Open Well Instability The SIRO method is an in vitro diagnostic test for the quantitative measurement of sirolimus in whole blood on the Dimension clinical chemistry system.. Reason: Siemens Healthcare Diagnostics has received customer complaints regarding QC shifts and imprecision after one day when using Dimension¿ SIRO lot EB6064. They have confirmed SIRO lot # EB6064 does not meet the open well stability claim of 2 days..
- Recalling firm
- Siemens Healthcare Diagnostics, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2016-02-09
- Terminated
- 2018-06-12
- 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
Dimension clinical chemistry system, Sirolimus (SIRO) Flex reagent cartridge (DF306 SMN 10464331) Lot EB6064, Open Well Instability The SIRO method is an in vitro diagnostic test for the quantitative measurement of sirolimus in whole blood on the Dimension clinical chemistry system.
Reason for recall
Siemens Healthcare Diagnostics has received customer complaints regarding QC shifts and imprecision after one day when using Dimension¿ SIRO lot EB6064. They have confirmed SIRO lot # EB6064 does not meet the open well stability claim of 2 days.
Data sourced from openFDA. This site is unofficial and independent of the FDA.