FDA Enforcement
Class II
Terminated
ADVIA Centaur¿ Folate Ascorbic Acid/Ascorbic Acid Diluent; SMN 10316877. Used to prepare the Red Blood Cell hemolysate for use with the ADVIA Centaur systems folate assay.
Recall: Z-2739-2015
·
Reported September 16, 2015
Enforcement
- Recall Number
- Z-2739-2015
- Event ID
- 71843
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Siemens Healthcare Diagnostics, Inc
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- September 16, 2015
- Initiation Date
- July 27, 2015
- Classification Date
- September 4, 2015
- Termination Date
- February 26, 2016
- Address
- 333 Coney St, N/A, East Walpole, MA, 02032-1516, United States
Description
ADVIA Centaur¿ Folate Ascorbic Acid/Ascorbic Acid Diluent; SMN 10316877. Used to prepare the Red Blood Cell hemolysate for use with the ADVIA Centaur systems folate assay.
Reason
Low red blood cell control recoveries and low results for red blood cell patient samples when using the ADVIA Centaur Systems Folate assay.
Code Info
Lot Number/Expiration: 54942 2015-11-17; 56230 2015-11-17; 70673 2015-11-17
Distribution
Worldwide Distribution-US (nationwide) including the states of CA CT DE FL GA IA IL IN KS KY MA MD MI MO NJ NM NV NY OH PA RI SC TN TX VA WA WI and OUS: Belgium Estonia Finland France Germany Great Britain Ireland Italy Pakistan Spain Sweden Switzerland Turkey.
Quantity
466