News & Topics

Announcement on medical device recall

(degree of risk 3) In accordance with Article 34 of the Medical Devices Act, we hereby announce the recall of the following medical devices.
* Medical device sellers, medical institutions, etc. that are storing the above medical devices are requested to immediately stop selling and using them and cooperate with the recall so that the person responsible for the recall can take action.

1. Item Name: 기타임상화학검사시약 II

2. Product Name: -

3. model name: AMMONIA TEST KIT ll™

4. Permit/Certification/Report Number: 체외 수인 13-2445 호

5. Classification number, grade: J20020.02 (2)

6. Manufacturing number or lot number: 4B61

7. Date of manufacture or expiration date: August 1, 2025

8. Reason for recall: Among the specifications listed in the product technology requirements, the accuracy specification is stated as 85-115 N-μg/dL when measuring the standard solution, but the test result of the above lot was 81.0 N-μg/dL.When measuring the standard solution, the sensitivity is lower than the required specification. When measuring the patient's blood with the problematic Amicheck, the test result will be around 81μg/dL, but it does not fall below the standard range of 75μg/dL, so there are no cases of misdiagnosing hyperammonemia patients as normal, and it is thought that there will be no health damage due to oversight. Additionally, there have been no reports of health damage to date.

9. Recall method and seller cooperation, etc: Disposal

10. Action to be taken by the consumer: Contact the customer service center indicated on the product or return it to the place of purchase.