All automatic dyeing devices for biopsy introduced by Abbott Korea have become the targets of recall by the Ministry of Food and Drug Safety, it was learned.

According to the ministry, the regulator has recently put Abbott Korea’s automatic dyeing device, Alinity h-series, on its list subject to recall. Of the 16 units imported to Korea, 15 will be recalled. Each unit was produced between July 2019 and September 2021.

Alinity h-series is composed of an automatic dyeing device for biopsy and an automatic blood cell calculator, the Alinity hs module.

The ministry said that as the cybersecurity certificate period for the medical devices expired on Sept. 8, each unit has become unusable.

“Every time the software checks the expiration date of the cybersecurity authentication, it detects the expiration of the date, and SCC (system control center) and LUI (local user interface) will not function. And that prevents Alinity h-series from processing samples,” it explained.

The ministry added that the issue has no impact on the cybersecurity or completeness of results concerning the Alinity h-series.

Abbott Korea is responding to the recall measures by visiting the inspection room and updating the software, according to the regulator.