Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Pacific Hemostasis FDP (Fibrinogen Degradation Products) Assay Kit (30 Determinations) Recalled by Fisher Diagnostics Due to An issue was discovered with the Pacific Hemostasis...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Fisher Diagnostics directly.
Affected Products
Pacific Hemostasis FDP (Fibrinogen Degradation Products) Assay Kit (30 Determinations), REF/Model 100650, UDI 00845275000863, IVD; --- Fisher Diagnostics, a division of Fisher Scientific Company LLC ,a part of Thermo Fisher Scientific Inc., Middletown, VA 22645-1905 USA --- For determination of Fibrinogen Degradation products in serum and urine.
Quantity: 331 units
Why Was This Recalled?
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.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Fisher Diagnostics
Fisher Diagnostics has 4 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report