Reported Apr 29, 2020 · Terminated
Siemens N Latex CDT Kit- IVD quantitative determination of carbohydrate-deficient transferrin (CDT) in human serum.…
CSL Behring GmbH
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: CSL Behring GmbH · Emil-Von-Behring-Str. 76 · Marburg, N/A · N/A
Is this the product you have?
- Siemens N Latex CDT Kit- IVD quantitative determination of carbohydrate-deficient transferrin (CDT) in human serum
- Siemens Material Number (SMN)10445997
- Lot codes and dates
- US Lot number49822
- UDI842768018534
- OUSLot
- numbers
49729498494998550084 Exp
- Date2020-04-11
- Amount recalled
- 297 PCK US; 1247 PCK OUS
Where it was sold
Why it was recalled
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
This product could cause temporary or reversible health problems — stop using it.
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