International safety notice

Acriva's "Hemochron Test Cartridge (Model: JACT-LR)" was purchased from a domestic customer facility. In one lot (J3JLR204), the lot has a model number (JACT+) that is different from the display on the outer box and individual packaging. (J3JAC247) has been reported. As a result, it was discovered that a different product was accidentally mixed into some of the products in the lot during the manufacturing process. Did.

Japan / PMDA Recalls · JPN · Apr 5, 2024

Key facts

Title Acriva's "Hemochron Test Cartridge (Model: JACT-LR)" was purchased from a domestic customer facility. In one lot (J3JLR204), the lot has a model number (JACT+) that is different from the display on the outer box and individual packaging. (J3JAC247) has been reported. As a result, it was discovered that a different product was accidentally mixed into some of the products in the lot during the manufacturing process. Did.
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 J3JLR204
Date Apr 5, 2024
Regulator page info.pmda.go.jp

At a glance

  • No Recall
  • No Field safety notice

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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

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