Laboratory diagnostic reagent distributed with incorrect calibration value on package label
Fisher Diagnostics is recalling Pacific Hemostasis Thromboplastin-D reagent (1,699 units) due to an incorrect International Sensitivity Index (ISI) value printed on the box. No illnesses or injuries have been reported.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class II recall with no reported illnesses or injuries. The defect is a labeling error—an incorrect printed reference value—without evidence of patient harm, fitting the 'minor labeling errors' category.
Plain-English summary
Fisher Diagnostics is recalling Pacific Hemostasis Thromboplastin-D, a 10 ml diagnostic reagent used in performing one-stage prothrombin time (PT) tests and factor assays. The recall affects 1,699 units distributed to Pennsylvania and the United Arab Emirates, including lot 665150 with an expiration date of January 31, 2027.
The product label contains an incorrect value for the International Sensitivity Index (ISI), a reference value used in PT test result interpretation. The outer box label displays the wrong ISI value, which could affect proper use and calibration of the reagent.
Healthcare providers and clinical laboratories currently using this product should contact Fisher Diagnostics to verify the correct ISI value for their specific lot and take appropriate corrective action. No illnesses or injuries related to this issue have been reported to the FDA.
The recalled product
- Product
- Pacific Hemostasis Thromboplastin-D, 10 ml. Used in performing one-stage prothrombin time test and factor assays.
- Manufacturer
- Fisher Diagnostics
- Hazard
- labeling-error
- incorrect-calibration-value
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- Catalog No. 100357
- UDI: 00845275000798665150270131100357
- Lot No. 665150
- Exp. Date 01/31/2027.
Distribution
Distributed in 1 state:
- PA
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