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
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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
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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 |
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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.
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510(K) Database | 510(K)s with Product Code = KQJ
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