FDA recall Z-2763-2017

Product

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

USA (nationwide) including Puerto Rico, and Internationally to Colombia

Key facts

Status

Terminated

Initiation date

2017-05-19

Report date

2017-08-02

Termination date

2018-06-29

Voluntary/Mandated

Voluntary: Firm initiated

Location

Middletown, VA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2763-2017