Z-2762-2017 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- August 2, 2017
- Initiation Date
- May 19, 2017
- Termination Date
- June 29, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 331 units
Product Description
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.
Reason for Recall
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.
Distribution Pattern
USA (nationwide) including Puerto Rico, and Internationally to Colombia
Code Information
Lot Number 948546, Exp. 9/30/2017