Recall Z-2763-2017— Fisher Diagnostics

Name: FDA recall Z-2763-2017
Creator: U.S. Food and Drug Administration
Published: 2017-05-19

Class II · Terminated

Class II FDA medical device recall by Fisher Diagnostics, initiated 2017-05-19, terminated 2018-06-29. It names one FDA 510(k) clearance: K800826. 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: 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..

Recalling firm: Fisher Diagnostics
Classification: Class II
Status: Terminated
Initiated: 2017-05-19
Terminated: 2018-06-29
Firm location: Middletown, VA, United States

510(k) clearances named in this recall

1 on FDA's record

K800826 — FIBRINOGEN SCREENPacific Hemostasis·cleared 1980-05-30

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.