Hello,
I just noticed that our packaging department covers medical device symbols on the blood collection tube with our own label. The symbols that are covered are temperature limit, fragile, read IFU and caution. This happens because they need to label the device with an internal barcode before shipping the tube to doctors for use. If they stick our label directly to the glass, it falls off, so they stick it on part of the already existing label.
LOT number, expiry date, CE IVD mark are not covered.
The blood tube is made by other manufacturer. We buy it in bulk and pack each separately in the package (along with other materials) that is later used by the doctor.
Could covering part of the symbols be problematic, and what kind of problems / non-conformance could that be?
I just noticed that our packaging department covers medical device symbols on the blood collection tube with our own label. The symbols that are covered are temperature limit, fragile, read IFU and caution. This happens because they need to label the device with an internal barcode before shipping the tube to doctors for use. If they stick our label directly to the glass, it falls off, so they stick it on part of the already existing label.
LOT number, expiry date, CE IVD mark are not covered.
The blood tube is made by other manufacturer. We buy it in bulk and pack each separately in the package (along with other materials) that is later used by the doctor.
Could covering part of the symbols be problematic, and what kind of problems / non-conformance could that be?