Dear Valuated Customers:
In order to improve the product regulatory compliance, we have made the following update to the instruction for use of the Disposable Swab and Sample Preservation solution:
For Disposable Swab：
Regarding the storage condition, as the sealed swab package will not be affected by the humidity, we replace the original expression “The swab should be stored in an environment where the relative humidity does not exceed 80%, the temperature does not exceed 40°C, with good ventilation and no corrosive gas. ”to “The product should be stored in a dry, ventilated, non-radiation and no corrosive gas clean room.”
In the Precaution, according to the (EU) 2017/745, Annex I, section 23.4. (z) we add the point: “If there is any serious incident occurs in relation to the device, please report to the manufacturer and the competent authority in your country immediately.”
For Sample Preservation Solution：
Add the disposable swab-related information into the sample preservation solution’s instruction for use.
We apologize for the affection already caused.
Please refer the updated instruction for use for more details:
Sample preservation solution instruction for use.pdf
Disposable Swab instruction for use.pdf
Sincerely.
Jiangsu Mole Bioscience Co., Ltd.
