April 1, 2025
PHC Corporation
PHC Corporation (Headquarters: Chiyoda-ku, Tokyo; President: Nobuaki Nakamura; hereafter referred to as "PHC"), a subsidiary of PHC Holdings Corporation (Headquarters: Chiyoda-ku, Tokyo; President: Kyoko Deguchi), announces that it has identified an issue with "PATHFAST hs-cTnI," an in vitro diagnostic reagent, manufactured in May 2024 for global markets. In response to this issue, PHC has decided to voluntarily recall the affected products.
We kindly request customers using the affected products to immediately discontinue their use. PHC representatives will contact customers to arrange the collection of the affected products.
We deeply regret any inconvenience or concern this situation may cause and extend our sincere apologies to our valued customers, suppliers, and all other stakeholders. Moving forward, we are committed to further enhancing our safety and quality control measures to prevent similar incidents. We sincerely appreciate your understanding and cooperation in this matter.
Detail of the Incident
1. Name of the affected product, model, and number of units
| Product name |
Product number |
Serial numbers |
Production period |
Number of units |
| PATHFAST hs-cTnI |
PF1241-K |
A457 |
May 2024 |
2053 kit |
2. Description of the issue and cause
(1) During an internal quality review, it was discovered that a cartridge lacked the ALP-labeled reagent, a critical component for accurate measurements.
(2) It was confirmed that measurements using the affected cartridges could potentially display a value of 0 ng/L, regardless of the actual sample concentration.
(3) As this issue could lead to missed detection of positive samples and delays in initiating treatment, a voluntary recall of the affected products is going to be conducted.
(4) The cause is believed to be a combination of improper filling during the manufacturing process and a malfunction in the detection sensor used to confirm reagent filling. A detailed investigation into the root cause is ongoing.
3. Response to our customers
The delivery destinations of the affected products have been identified. Our representatives will reach out to provide the necessary information and proceed with a voluntary recall.
4. Reported Damages
To date, no injuries, health-related incidents, or damages have been reported.
Contact information: Atsushi Miyamoto
PHC Corporation, In Vitro Diagnostics Division, Narita Plant, IVD Quality Assurance Department
1460-6 Aza-Mitodai, Mito, Tako-machi, Katori-gun, Chiba, Japan
Phone number: 0479-76-3706
Fax number: 0479-76-3864