Biotech companyLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in GermanyLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field., part of CSL. FDA records under 5 spellings of its name, each linked to the record. See the CSL group view.
As of Nov 13, 2026, FDA's public records list CSL Behring with 5 device recalls, 2 warning letters, 1 complete response letter, 1 drug application and 1 OPDP letter. The most recent is a warning letter dated May 13, 2026: Warning letter: Biologics.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Date | Record | Source |
|---|---|---|
| May 13, 2026 | Warning letter: BiologicsCBER | Warning letters |
| Sep 9, 2025 | Warning letter: Aseptic processingCBER | Warning letters |
| Sep 9, 2025 | Warning letter: HIZENTRAOffice of Prescription Drug Promotion | OPDP letters |
| Oct 7, 2024 | Complete response letter, BLA 761367Approved | Complete response letters |
| Mar 2, 2020 | Siemens N Latex CDT Kit- IVD quantitative determination of carbohydrate-deficient transferrin (CDT) in human serum. Siemens Material NumberClass II · Negative bias for the carbohydrate-deficient transferrin (CDT) measurement in comparison to the HPLC method, observed t | Device recalls |
| May 31, 2018 | N Latex CDT KitClass II · Siemens Healthcare Diagnostics has observed a negative bias for the carbohydrate-deficient transferrin (CDT) measurement | Device recalls |
| Jun 5, 2017 | SIEMENS N/T Protein Control SL for use on the BN II, BN ProSpec Systems: N/T Protein Control SL/L: REF/Product Code OQIN19, SMN 10446079 (LoClass II · Siemens Healthcare Diagnostics has confirmed a negative bias of approximately -20% for results obtained with N Antiserum | Device recalls |
| Jun 5, 2017 | SIEMENS N Protein Standard SL, for use on the BN II, BN ProSpec Systems, REF/Product Code OQIM 13, Siemens Material Number (SMN)10446073Class II · Siemens Healthcare Diagnostics has confirmed a negative bias of approximately -20% for results obtained with N Antiserum | Device recalls |
| May 17, 2016 | Dimension Vista¿ Homocysteine Flex Reagent Cartridge (HCYS), Device Listing No.: D017878 is an in vitro diagnostic test for the quantitativClass II · Reagent lots # 15243MA and 15243MB shows a reduced stability once opened that does not meet the Instructions For Use cla | Device recalls |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
