CSL Behring GmbH
Medical device manufacturer in Marburg, Germ.
0510(k) clearances
0PMA approvals
5recalls
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-1790-2020 Class II | Siemens N Latex CDT Kit- IVD quantitative determination of carbohydrate-deficient…Negative bias for the carbohydrate-deficient transferrin (CDT) measurement in comparison to the HPLC method… | 03/02/2020Terminated |
| Z-2931-2018 Class II | N Latex CDT KitSiemens Healthcare Diagnostics has observed a negative bias for the carbohydrate-deficient transferrin (CDT)… | 05/31/2018Terminated |
| Z-0191-2018 Class II | SIEMENS N/T Protein Control SL for use on the BN II, BN ProSpec Systems: N/T Protein…Siemens Healthcare Diagnostics has confirmed a negative bias of approximately -20% for results obtained with… | 06/05/2017Terminated |
| Z-0190-2018 Class II | SIEMENS N Protein Standard SL, for use on the BN II, BN ProSpec Systems, REF/Product…Siemens Healthcare Diagnostics has confirmed a negative bias of approximately -20% for results obtained with… | 06/05/2017Terminated |
| Z-2241-2016 Class II | Dimension Vista Homocysteine Flex Reagent Cartridge (HCYS), Device Listing No.: D017878…Reagent lots # 15243MA and 15243MB shows a reduced stability once opened that does not meet the Instructions… | 05/17/2016Terminated |