Fisher Diagnostics recalls Pacific Hemostasis Thromboplastin-D, 4 ml. Used in performing one-stage prothrombin time test and factor assays.
- Recall date
- March 6, 2025
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-1502-2025
- FDA classification
- Class II
- Brand / firm
- Fisher Diagnostics
- Sold / distributed
- US Distribution to: PA and OUS Foreign country of: United Arab Emirates.
Why it was recalled
The incorrect value of the International Sensitivity Index (ISI) is printed on the outer box label.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
Pacific Hemostasis Thromboplastin-D, 4 ml. Used in performing one-stage prothrombin time test and factor assays.
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