Fisher Diagnostics recalls Pacific Hemostasis Thromboplastin-D 4ml kits due to incorrect International Sensitivity Index (ISI) value printed on outer box labels. This may affect lab test accuracy.
The incorrect value of the International Sensitivity Index (ISI) is printed on the outer box label.
Fisher Diagnostics is recalling Pacific Hemostasis Thromboplastin-D 4ml test kits because the International Sensitivity Index (ISI) value on the outer box label is incorrect. This could lead to inaccurate blood test results if used in medical testing.
The incorrect ISI value printed on the outer box label can cause inaccurate blood test results when used in one-stage prothrombin time tests and factor assays. This may lead to incorrect medical decisions based on the test results.
Healthcare professionals using these kits for blood tests are most likely affected. Patients receiving tests using these kits may experience inaccurate results.
Check for Pacific Hemostasis Thromboplastin-D 4ml kits with catalog number 100356 and lot number 719170. These were sold between 2023 and 2026.
Verify the International Sensitivity Index (ISI) value on the outer box label matches the correct value for accurate test results.
No, this recall is for potential inaccurate test results due to an incorrect ISI value on the label, not a safety hazard.
Check for Pacific Hemostasis Thromboplastin-D 4ml kits with catalog number 100356 and lot number 719170.
Check the ISI value on the label; if incorrect, contact Fisher Diagnostics for guidance on next steps.
We’ve drafted a message you can send Fisher Diagnostics to request your refund or repair — edit it as you like.
Subject: Recall Z-1502-2025 — Fisher Diagnostics Fisher Diagnostics Hello, I own a Fisher Diagnostics that is covered by recall Z-1502-2025 from Fisher Diagnostics. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
