RE: Some Questions for the Company15 Feb 2024 19:41
You need to read again .
REASON FOR THE FIELD ACTION
It has been identified that the devices listed in Table 1 suffer a degradation in performance following
prolonged storage at ≥40°C. This degradation in performance manifests itself in the production of a
‘Test Failed’ result, when tests at a low target copy number, are performed.
The storage temperature conditions for the Genedrive® MT-RNR1 ID Kits are 2-30°C. The degradation
in performance at ≥40°C identified, however, could indicate that the labelled shelf life of these kits may
be compromised.
DESCRIPTION OF THE ISSUE
The issue is linked to the manufacture of a specific raw material lot used in the impacted Genedrive®
MT-RNR1 ID Kit lots. There is no reason to question the performance of other Genedrive® MT-RNR1
ID Kit lots.