Diagnostic reagent recalls incorrect ISI value on Pacific Hemostasis Thromboplastin-D
Fisher Diagnostics is recalling Pacific Hemostasis Thromboplastin-D due to an incorrect International Sensitivity Index (ISI) value printed on the outer box label. The error could affect interpretation of prothrombin time test results.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II labeling error on a critical diagnostic reagent. The incorrect ISI value creates a risk of improper test interpretation, meeting the criterion for 'risk-of-harm products where injury has not yet been reported.' No illnesses or injuries have been documented.
Plain-English summary
Fisher Diagnostics is recalling Pacific Hemostasis Thromboplastin-D, a diagnostic reagent used in performing one-stage prothrombin time tests and factor assays. The recall is due to an incorrect International Sensitivity Index (ISI) value being printed on the outer box label. The ISI is critical for proper calculation and interpretation of test results.
The affected product has Catalog No. 100356, UDI 00845275000542719170261130100356, Lot No. 719170, and an expiration date of November 30, 2026. Approximately 4,387 units were distributed in the United States (primarily Pennsylvania) and internationally to the United Arab Emirates.
An incorrect ISI value on the label could lead to improper interpretation of prothrombin time test results.
The recalled product
- Product
- Pacific Hemostasis Thromboplastin-D, 4 ml. Used in performing one-stage prothrombin time test and factor assays.
- Manufacturer
- Fisher Diagnostics
- Affected units
- 4,387
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. 100356
- UDI: 00845275000542719170261130100356
- Lot No. 719170
- Exp. Date 11/30/26.
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 2 recalled by Fisher Diagnostics under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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