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.
Reported: May 18, 2016 Initiated: February 9, 2016 #Z-1633-2016
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.
Details
- Recalling Firm
- Siemens Healthcare Diagnostics, Inc.
- Units Affected
- 394
- Distribution
- Worldwide distribution and US including Puerto Rico and to the states of : TX, FL, CA, LA, DC, GA, IL, AR, WI, MI and MD.
- Location
- Newark, DE
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Siemens Healthcare Diagnostics, Inc.. Units affected: 394.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 18, 2016. Severity: Moderate. Recall number: Z-1633-2016.
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