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
    • 49729
    • 49849
    • 49985
    • 50084 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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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Oct 5, 2020 · Data as of Sep 19, 5:33 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.