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Corrective action of Roche for Integra HbA1c
2005.02.24
Product group In-vitro diagnostics
Reference 00162/05
Corrective action of Roche for Integra HbA1c (lot number 663707 and 666830). Due to a batch inhomogeneity erroneous results for HbA1c may be obtained. The manufacturer informed the customers about the problem and how to prevent it. The number of affected batches listed in the manufacturer's customer information from January 27th has been extended (BfArM case number 0162/05 from February 3rd 2005).
Advisory notice is only available in German language.
Corrective action of Roche for Integra HbA1c , Download_VeroeffentlichtAm_EN