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U.S. Department of Health and Human Services

Class 2 Device Recall Pacific Hemostasis Fibrinogen Degradation Products

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  Class 2 Device Recall Pacific Hemostasis Fibrinogen Degradation Products see related information
Date Initiated by Firm May 19, 2017
Create Date July 25, 2017
Recall Status1 Terminated 3 on June 29, 2018
Recall Number Z-2762-2017
Recall Event ID 77340
510(K)Number K800826  
Product Classification System, fibrinogen determination - Product Code KQJ
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.
Code Information Lot Number 948546, Exp. 9/30/2017
Recalling Firm/
Manufacturer		 Fisher Diagnostics
8365 Valley Pike
Middletown VA 22645-1905
For Additional Information Contact Jeffrey J. Fisher
540-869-8188
Manufacturer 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 Determined
Cause 2		 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
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = KQJ and Original Applicant = PACIFIC HEMOSTASIS
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