CSL Behring GmbH

FDA Regulatory Profile

Summary

Total Recalls
5
510(k) Clearances
0
Inspections
13
Compliance Actions
1

Recent Recalls

NumberClassProductDate
Z-1790-2020Class IISiemens N Latex CDT Kit- IVD quantitative determination of carbohydrate-deficient transferrin (CDT) March 2, 2020
Z-2931-2018Class IIN Latex CDT KitMay 31, 2018
Z-0190-2018Class IISIEMENS N Protein Standard SL, for use on the BN II, BN ProSpec Systems, REF/Product Code OQIM 13, SJune 5, 2017
Z-0191-2018Class IISIEMENS N/T Protein Control SL for use on the BN II, BN ProSpec Systems: N/T Protein Control SL/L: RJune 5, 2017
Z-2241-2016Class IIDimension Vista¿ Homocysteine Flex Reagent Cartridge (HCYS), Device Listing No.: D017878 is an in vMay 17, 2016