Z-2762-2017Class II

Pacific Hemostasis FDP (Fibrinogen Degradation Products) Assay Kit (30 Determinations), REF/Model 100650, UDI...

Name: Z-2762-2017 Pacific Hemostasis FDP (Fibrinogen Degradation Products) Assay Kit (30 Determinations), REF/Model 100650, UDI...
Creator: Fisher Diagnostics
Published: 2017-05-19
License: https://open.fda.gov/license/

Fisher Diagnostics / initiated 2017-05-19 / Terminated

FDA source

Fisher Diagnostics began a recall of Pacific Hemostasis FDP (Fibrinogen Degradation Products) Assay Kit (30 Determinations), REF/Model 100650, UDI 00845275000863, IVD; --- Fisher Diagnostics, a... on 2017-05-19. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2762-2017
Classification: Class II
Status: Terminated
Initiated: 2017-05-19
Posted: 2017-07-25
Terminated: 2018-06-29
Recalling firm: Fisher Diagnostics
Product: 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 code: KQJ System, Fibrinogen Determination
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.
FDA root cause: Under Investigation by firm
Action: 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.
Quantity in commerce: 331 units
Distribution: USA (nationwide) including Puerto Rico, and Internationally to Colombia
Product codes and lots: Lot Number 948546, Exp. 9/30/2017

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2762-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2762-2017	Class II	Terminated	Voluntary: Firm initiated	2017-08-02	2017-07-25
Z-2763-2017	Class II	Terminated	Voluntary: Firm initiated	2017-08-02	2017-07-25

Product code KQJ

K800826Class IIFibrinogen ScreenPacific Hemostasis / cleared 1980-05-30

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)