Z-2763-2017 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
- 27 units
Product Description
Pacific Hemostasis FDP Latex Reagent, REF/Model Number 100651, UDI 00845275000870, 1 x 5 mL, IVD; --- Fisher Diagnostics, a division of Fisher Scientific Company, LLC, a part of Thermo Fisher Scientific Inc., Middletown, VA 22645-1905 USA
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 890199, Exp. 6/30/2018