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Fisher Diagnostics Recalls
4 recalls on record · August 2, 2017 to April 9, 2025 · Medical Devices
Recalls by year
17
25
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
April 9, 2025Medical DevicesFDA
Fisher Diagnostics recalls Pacific Hemostasis Thromboplastin-D, 10 ml. Used in performing one-stage prothrombin time test and factor assays.
Hazard: The incorrect value of the International Sensitivity Index (ISI) is printed on the outer box label.
April 9, 2025Medical DevicesFDA
Fisher Diagnostics recalls Pacific Hemostasis Thromboplastin-D, 4 ml. Used in performing one-stage prothrombin time test and factor assays.
Hazard: The incorrect value of the International Sensitivity Index (ISI) is printed on the outer box label.
August 2, 2017Medical DevicesFDA
Fisher Diagnostics recalls Pacific Hemostasis FDP Latex Reagent, REF/Model Number 100651, UDI 00845275000870, 1 x 5 mL, IVD; --- Fisher Diagnostics
Hazard: An issue was discovered with the Pacific Hemostasis Fibrinogen Degradation Products (FDP) kit, list number 100650, lot 948546 and FDP Latex Reagent, list 100651, lot 890199. While the kit performs accurately at FDP concentrations greater than 20 ¿g/ml, there is an observed reduction in sensitivity when FDP levels are less than 20 ¿g/ml. This reduction in sensitivity has been tied to FDP Latex Reagent lot 890199 and may result in false negatives.
August 2, 2017Medical DevicesFDA
Fisher Diagnostics recalls Pacific Hemostasis FDP (Fibrinogen Degradation Products) Assay Kit (30 Determinations), REF/Model 100650, UDI 008452750
Hazard: An issue was discovered with the Pacific Hemostasis Fibrinogen Degradation Products (FDP) kit, list number 100650, lot 948546 and FDP Latex Reagent, list 100651, lot 890199. While the kit performs accurately at FDP concentrations greater than 20 ¿g/ml, there is an observed reduction in sensitivity when FDP levels are less than 20 ¿g/ml. This reduction in sensitivity has been tied to FDP Latex Reagent lot 890199 and may result in false negatives.