Fibrinogen Screen

• 2 recalls, same reason

  • Terminated Z-2762-2017 FDA Class II ·initiated 19 May 2017
  • Terminated Z-2763-2017 FDA Class II ·initiated 19 May 2017

  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.

510(k) Number

K800826 ↗

FDA Product Code

KQJ

Device Class

Class II

Regulation

21 CFR Part 864.7340

Advisory Committee

Hematology

FDA Decision

SESE Substantially Equivalent

• Prothrombin Reference Plasma (Human)

  Class II

  FDA 510(k) K791022 Active Cleared 24 Jul 1979

• Pacific Hemostasis Immunodepleted Factor V Deficient Plasma (Thrombosdreen Brand) (100056)

  Class II

  FDA 510(k) K972627 Active Cleared 13 Aug 1997

• Thrombostrate Control Plasmas

  Class II

  FDA 510(k) K000679 Active Cleared 24 Mar 2000

• Thromboscreen Thromboplastin-Ds

  Class II

  FDA 510(k) K940082 Active Cleared 14 Feb 1995

• Antithrombin III Screen Kit

  Class II

  FDA 510(k) K812215 Active Cleared 1 Sep 1981

• Thromboscreen Aptt Reagent

  Class II

  FDA 510(k) K891337 Active Cleared 21 Apr 1989

See all devices from Pacific Hemostasis →