Fisher Diagnostics: Medical Device Recall in 2017 - (Recall #: Z-2762-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2017.

Data Source: FDA.

Product Description:

Pacific Hemostasis FDP (Fibrinogen Degradation Products) Assay Kit (30 Determinations), REF/Model 100650, UDI 00845275000863, IVD; --- Fisher Diagnostics, a division of Fisher Scientific Company LLC ,a part of Thermo Fisher Scientific Inc., Middletown, VA 22645-1905 USA --- For determination of Fibrinogen Degradation products in serum and urine.

Product Classification:

Class II

Date Initiated: May 19, 2017

Date Posted: August 2, 2017

Recall Number: Z-2762-2017

Event ID: 77340

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.

Status: Terminated

Product Quantity: 331 units

Code Information:

Lot Number 948546, Exp. 9/30/2017

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated