Medical device manufacturer, Coris BioConcept, has issued a field safety notice concerning its RESIST-3 O.K.N. K-set [Product code: SUN-1KR5; Model (lot number): Cassette (1KR5K1618); Catalogue number: K-15R5; Manufacturing date: 12 Dec 2016; Expiry date: 17 May 2017].
According to the manufacturer, there is a slight shift between the test lines OXA-48 (O) and KPC (K) of the strip and the labeled inscription on the cassette. Both test lines of strip are slightly lower than the letter 'O' and 'K' labeled on the cassette. The problem has been detected by a collaborative contact during some laboratory tests.
There is a potential risk of confusing the KPC line with the OXA-48 line when only the KPC signal is readable after the test. A wrong interpretation could impact the treatment received by the patient. The performance of the test is not altered at all and the affected lot meets the manufacturer's quality standards.
To facilitate interpretation of the result, it is recommended to indicate the position of the KPC green line before starting the test.
According to the local supplier, the affected products are distributed in Hong Kong.
If you are in possession of the products, please contact your supplier for necessary actions.
Posted on 15 February 2017