Corrective action of Roche for Unimate 3 HbA1c and Unimate 5 HbA1c
2005.03.14
Product group In-vitro diagnostics
Reference 00336/05
Corrective action of Roche for Unimate 3 HbA1c and Unimate 5 HbA1c (all batches). Due to a batch inhomogeneity erroneous results for HbA1c may be obtained. The manufacturer informed the customers about the problem and how to prevent ist. See also BfArM case number 0162/05 from February 3rd 2005.
Advisory notice is only available in German language.
Corrective action of Roche for Unimate 3 HbA1c and Unimate 5 HbA1c , Download_VeroeffentlichtAm_EN