Subject : 2nd notice

Dear All Distributors / Customers,

Further to below notice, we would like to add some more explanation on this filed notice for your understanding.

On Oct-15, we received an email from our CE representative (MT Promedt) that some of our COVID-19 test kits contained non-confirmed sample collection swabs as per the EC Directives and thus we were requested to make a action notice to stopping sales and distribution of this concerned lots until further notice.

Our SARS-CoV-2 Rapid Antigen Test contains test kit with different components. Among those, sample collection ‘swab’ (Legal manufacturer Huachenyang (Shenzhen) Technology Co., Ltd.) found inappropriate to be distributed in EU Countries due to lack of CE certification of a notified Body on it as per the EC Directives.

The Declaration of conformity for the swabs is relates to a IVD product (Directive 98/79/EC). This is incorrectly classified as the product is considered as medical device.

: the definition of IVD Directive 98/79/EC: Article 1, point 2c, 2. Paragraph:

"For the purposes of this definition, invasive sampling devices or those which are directly applied to the human body for the purpose of obtaining a specimen within the meaning of Directive 93/42/EEC shall not be considered to be accessories to in vitro diagnostic medical devices."

Furthermore the swabs are labeled as sterile products, but no certificate of a Notified Body is available.

Based on the urgency we were recommend the following actions:

• Contact your distributor and require stopping sales and distribution of the concerned batch/batches that contain this swab.
• Define options of any corrective actions (repacking with correctly labeled swabs)
• Perform vigilance report in the affected countries with Field Safety Corrective Action (FSCA) if applicable
• Identify any other of your product portfolio (procedure packs) that contain the related swabs and initiate CAPA actions
• Contact your supplier of the swab to initiate relevant CAPA measures regarding labeling, certification and others

Now we are discussing with German Authorities for the following-up actions.

We are not sure what corrective actions will be demanded from the competent national authority for those shipped products but expect one of the followings:

1.     Continue use those distributed kits by providing further evidence that those sample swap has no harm to the human body and equal quality to those CE certified goods.

2.     Replace those unapproved sample swaps to CE certified swap by the Notified Body in your side and continue sell/distribute.

3.     Recall all Corresponding kits and return it to us.

If we have to provide new swaps with CE certified by the notified body, we will send it to you shortest possible so that you can provide correct one to the customers without problem. (We will secure plenty of certified swaps immediately)

If recall requested, all those unused kits should be shipped back to us for repackaging.

We will do our best to settle this issue soonest possible as per the direct from our notify body and related authority.

In case of any questions please contact us immediately.

Thank you in advance for your understanding and continued cooperation with us.

Best regards,

----- Original Message -----
From : Jason Jo_SD Biosensor <jason@sdbiosensor.com>
To : <taylor@sdbiosensor.com>
Cc : <brucker@mt-procons.com>, <ear@mt-procons.com>, "yschosd" <yschosd@sdbiosensor.com>, "이효근 사장님" <hklee@sdbiosensor.com>, "taylor" <taylor@sdbiosensor.com>, "송근국" <gksong@sdbiosensor.com>, "조혜임" <scho@sdbiosensor.com>, "정인철본부장님" <chungi@sdbiosensor.com>, "임규희" <khlim@sdbiosensor.com>, "왕영이" <yywang@sdbiosensor.com>, "길정로" <jrgil@sdbiosensor.com>, "Choi Byung kwan" <kevin@sdbiosensor.com>, "지소현" <sohyun@sdbiosensor.com>, "양희환" <victor@sdbiosensor.com>, "이유진" <yujin.lee@sdbiosensor.com>, "조상협" <jason@sdbiosensor.com>, "Cedric" <cedric@sdbiosensor.com>
Sent : 2020-10-16 20:35:54
Subject : Subject : Stopping sales and distribution of concerned batches of STANDARD Q COVID-19 Ag Test