FDA Medical devices recall ·
Pacific Hemostasis Thromboplastin-D, 4 ml recall
- Recall number
- Z-1502-2025
- Date
- (initiated March 6, 2025)
- Company / brand
- Fisher Diagnostics
8365 Valley Pike, Middletown, VA, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 4,387 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Pacific Hemostasis Thromboplastin-D, 4 ml. Used in performing one-stage prothrombin time test and factor assays.
Why was it recalled?
The incorrect value of the International Sensitivity Index (ISI) is printed on the outer box label.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Catalog No. 100356; UDI: 00845275000542719170261130100356; Lot No. 719170; Exp. Date 11/30/26.
Distribution
US Distribution to: PA and OUS Foreign country of: United Arab Emirates.
States: Pennsylvania
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-1502-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.