Middletown, VA, United States
Fisher Diagnostics recalls
1 recall recorded since 2018, most recently on 6 March 2025. 1 is listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)1
Terminated or completed0
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 6 March 2025
- Reason
- The incorrect value of the International Sensitivity Index (ISI) is printed on the outer box label.
- Distribution
- US Distribution to: PA and OUS Foreign country of: United Arab Emirates.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1502-2025, Z-1503-2025
- Pacific Hemostasis Thromboplastin-D, 4 ml. Used in performing one-stage prothrombin time test and factor assays.
- Pacific Hemostasis Thromboplastin-D, 10 ml. Used in performing one-stage prothrombin time test and factor assays.
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.