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
This recall has been terminated (originally issued May 19, 2017).
- Company
- Fisher Diagnostics
- Recall Initiated
- May 19, 2017
- Terminated
- June 29, 2018
- Recall Number
- Z-2763-2017
- Quantity
- 27 units
- Firm Location
- Middletown, VA
- Official Source
- View on FDA website ↗
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
USA (nationwide) including Puerto Rico, and Internationally to Colombia
Lot / Code Info
Lot Number 890199, Exp. 6/30/2018
Root Cause
Under Investigation by firm
Action Taken
ThermoFisher Scientific sent an MEDICAL DEVICE RECALL Letter dated May 16, 2017, to all affected customers and response forms were sent to customers on May 19, 2017. Customers are informed of the recall and potential health risks and instructed to review their test results. Review your inventory and any product on hand is to be discarded. --- The firm ceased distribution of the lots and began its investigation. The held product will ultimately be destroyed. Level A effectiveness checks will be conducted to the consignees and repeated attempts will be made to non-responding customers. The firm will track all mailed, emailed and faxed return forms for the duration of the recall. For further questions, please call (540) 869-8188.