Fisher Diagnostics recalls Pacific Hemostasis Thromboplastin-D (10ml) due to incorrect International Sensitivity Index value printed on the outer box label. This could 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 (10ml) because the International Sensitivity Index (ISI) value on the label is incorrect. This could lead to inaccurate lab test results if used without correction.
The incorrect ISI value printed on the outer box label can lead to inaccurate blood clotting test results. This might cause incorrect diagnoses or treatment decisions if the lab uses the product without checking the label.
Lab technicians and healthcare providers who use this product for blood clotting tests may be affected. Those using the product without verifying the ISI value could get inaccurate test results.
Check for the Pacific Hemostasis Thromboplastin-D product with catalog number 100357 and lot number 665150. The product expires on January 31, 2027.
Check the International Sensitivity Index (ISI) value on the outer box label to ensure it matches the correct value for accurate test results.
No, the product is safe if the ISI value is verified and the correct value is used for testing.
Look for catalog number 100357 and lot number 665150 on the product label. The product expires on January 31, 2027.
No, you can continue using it as long as you verify the ISI value on the label before each test.
We’ve drafted a message you can send Fisher Diagnostics to request your refund or repair — edit it as you like.
Subject: Recall Z-1503-2025 — Fisher Diagnostics Fisher Diagnostics Hello, I own a Fisher Diagnostics that is covered by recall Z-1503-2025 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.