[비즈한국] It has been confirmed that GC Biopharma MS142280 is voluntarily recalling some personal blood glucose test strips and meters due to minor quality defects. While the risk level is low, the potential for blood glucose levels to be measured higher than the actual values could lead to patients overdosing on insulin.
According to the Ministry of Food and Drug Safety (MFDS) and the medical device industry on the 13th, GC Biopharma MS began a voluntary recall of its personal blood glucose test strips and meters on the 10th. The reason for the recall is the 'possibility that blood glucose measurements may be slightly higher than actual levels.'
The MFDS classified this as a Class 3 risk level, which implies that side effects are rare or minor.
However, a blood glucose meter is an essential medical device that diabetic patients use daily to check their health status and determine insulin dosage. If the device displays higher figures than the actual blood glucose levels, as in the case of this defect, there is a risk that the patient may mistake it for hyperglycemia and administer an excessive amount of insulin. Experts point out that this is a significant safety issue that cannot be dismissed as a mere error, as it could lead to a rapid drop in blood glucose, potentially resulting in loss of consciousness or hypoglycemic shock.
The total volume subject to this recall reaches 141,401 units. The personal blood glucose test strips (model name GGS-100), which account for the largest portion, will see 122,667 units recalled. Given that the product is traded at approximately 15,000 KRW per box (50 strips) in pharmacies and online malls, this means that defective test strips worth approximately 1.8 billion KRW based on retail prices have been identified. These test strips have been GC Biopharma MS's mainstay entry-level product for over 10 years since their approval in 2014.
The personal blood glucose meters included in the recall are new products launched in October last year. A total of 18,734 devices are subject to the recall, including 869 units of the GC Fit Pro Personal Blood Glucose Meter (GGM-100b) and 17,865 units of the GC Fit CHECK Blood Glucose Monitoring System, GC Fit On Blood Glucose Monitoring System, and Now Care Plus Blood Glucose Monitoring System (GGP-100c, etc.).
This is not the first time GC Biopharma MS has faced controversy regarding quality. According to MFDS medical device recall and sales suspension information, the company also implemented a recall for some manufacturing numbers (a total of 4 sets) of the inflammation marker test reagent 'DiaSys CRP FS' in November last year. The reason for the recall at that time was also an accuracy issue, where results for low-concentration samples were measured lower than actual values.