Csl Behring recalls
Csl Behring appears in 5 official U.S. recall notices indexed by RecallRadar, most recently on 2020-04-29.
Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.
Recall summary
| Recall notices | 5 |
|---|---|
| Published | 2016-07-27 to 2020-04-29 |
| By agency | FDA Device (5) |
| By classification | Class II (5) |
| By status | terminated (5) |
| Distribution named in notices | AL, AR, CA, CO, CT, DC, DE, FL, GA, IA, IL, IN, KS, LA, MA, MD, MI, MO, MS, MT, NC, NE, NH, NJ, NV, NY, OH, OR, PA, RI, SC, TN, TX, UT, VA, WI, WV |
Recalls
- Siemens N Latex CDT Kit- IVD quantitative determination of carbohydrate-deficient transferrin (CDT) in human serum
FDA Device · Class II · 2020-04-29 · Csl Behring
Reason: Negative bias for the carbohydrate-deficient transferrin (CDT) measurement in comparison to the HPLC method, observed to occur after 15 months based on shelf life monitoring - N Latex CDT Kit
FDA Device · Class II · 2018-09-05 · Csl Behring
Reason: Siemens Healthcare Diagnostics has observed a negative bias for the carbohydrate-deficient transferrin (CDT) measurement when using the affected N Latex CDT lots in comparison to the HPLC method. CDT results in absolute… - SIEMENS N Protein Standard SL, for use on the BN II, BN ProSpec Systems, REF/Product Code OQIM 13, Siemens Material Number (SMN)10446073
FDA Device · Class II · 2017-12-06 · Csl Behring
Reason: Siemens Healthcare Diagnostics has confirmed a negative bias of approximately -20% for results obtained with N Antiserum to Human Ceruloplasmin when calibrating Ceruloplasmin with various lots of N Protein Standard SL.… - 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 (L…
FDA Device · Class II · 2017-12-06 · Csl Behring
Reason: Siemens Healthcare Diagnostics has confirmed a negative bias of approximately -20% for results obtained with N Antiserum to Human Ceruloplasmin when calibrating Ceruloplasmin with various lots of N Protein Standard SL.… - Dimension Vista¿ Homocysteine Flex Reagent Cartridge (HCYS), Device Listing No.: D017878 is an in vitro diagnostic test for the quantitativ…
FDA Device · Class II · 2016-07-27 · Csl Behring
Reason: Reagent lots # 15243MA and 15243MB shows a reduced stability once opened that does not meet the Instructions For Use claim of seven (7) days. A maximum bias of -37% was observed.