Marburg, N/A, Germany
CSL Behring GmbH recalls
2 recalls recorded since 2018, most recently on 2 March 2020. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls2
Ongoing (FDA)0
Terminated or completed2
Class I (FDA)0
Terminated Class II Medical devices
- Recall started
- 2 March 2020
- Terminated
- 5 October 2020
- 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
- Distribution
- IN, KS, MO, OH, VA Foreign: Australia, Austria, Bangladesh, Belgium, Canada, China Czech Republic, Egypt, Finland, France, Germany, Great Britain, Hungary India, Italy, Japan, Mexico, Netherlands, Norway, Poland, Portugal, Republic Korea, Russia Federation, Slovakia, Slovenia, South Africa, Spain
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1790-2020
- Siemens N Latex CDT Kit- IVD quantitative determination of carbohydrate-deficient transferrin (CDT) in human serum. Siemens Material Number (SMN): 10445997
Terminated Class II Medical devices
- Recall started
- 31 May 2018
- Terminated
- 12 February 2021
- 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 concentrations may be influenced by patients transferrin levels and, therefore, results are reported as ratio of CDT to total transferrin, called %CDT. As the transferrin determination with N Antiserum to Human Transferrin is not affected, the observed effect leads to calculated %CDT values that show a negative bias of approximately 15% compared to the HPLC method. This could result in a shift of weak positive patient samples into the reference range of 1.19 2.47 %CDT which was derived from a study population of healthy adults. There are no control or calibrator materials that would catch this bias.
- Distribution
- Domestic - DE, IN, KS, MO & VA Internationally - Australia Austria Belgium Canada China Czech Republic Finland France Germany Hungary India Italy Japan Latvia Lithuania Netherlands Norway Poland Portugal Saudi Arabia Slovakia Slovenia South Africa South Koria Spain Swed
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2931-2018
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.