International safety notice
One lot (H1JAC311) of "Hemoclone Test Cartridge (Model: JACT+)" manufactured by Acriva was received from a domestic trading facility. We received a report that a product (model: JACT-LR) that differs from the one shown on the outer box was mixed in. As a result of an investigation into the cause by the manufacturer, Acriva, Inc., it was discovered that during the manufacturing process, some of the products in the lot were mistakenly mixed with different products. It turned out that it was mixed in. Based on instructions from the manufacturer, we have decided to voluntarily recall the products in question.
Japan / PMDA Recalls · JPN · Apr 5, 2022
Key facts
| Title | One lot (H1JAC311) of "Hemoclone Test Cartridge (Model: JACT+)" manufactured by Acriva was received from a domestic trading facility. We received a report that a product (model: JACT-LR) that differs from the one shown on the outer box was mixed in. As a result of an investigation into the cause by the manufacturer, Acriva, Inc., it was discovered that during the manufacturing process, some of the products in the lot were mistakenly mixed with different products. It turned out that it was mixed in. Based on instructions from the manufacturer, we have decided to voluntarily recall the products in question. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: Elapsed time timer for coagulation measurements Sales name: Hemochron Test Cartridge |
| Manufacturer | Heiwa Bussan Co., Ltd. |
| Models | H1JAC311 |
| Date | Apr 5, 2022 |
| Regulator page | info.pmda.go.jp |
At a glance
- No Recall
- No Field safety notice
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About International device safety notices
Field safety notices, recalls and safety alerts published by about 30 national medical device regulators outside the United States, matched by Orca1 to FDA device data.
Source: National medical device regulators (as listed), compiled by Orca1