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U.S. Department of Health and Human Services

Class 2 Device Recall ThromboplastinD

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 Class 2 Device Recall ThromboplastinDsee related information
Date Initiated by FirmMarch 06, 2025
Date PostedMarch 31, 2025
Recall Status1 Open3, Classified
Recall NumberZ-1503-2025
Recall Event ID 96488
510(K)NumberK994100 
Product Classification Test, time, prothrombin - Product Code GJS
ProductPacific Hemostasis Thromboplastin-D, 10 ml. Used in performing one-stage prothrombin time test and factor assays.
Code Information Catalog No. 100357; UDI: 00845275000798665150270131100357; Lot No. 665150; Exp. Date 01/31/2027.
FEI Number 1181121
Recalling Firm/
Manufacturer		 Fisher Diagnostics
8365 Valley Pike
Middletown VA 22645-1905
For Additional Information ContactAsiyah Imam
800-528-0494
Manufacturer Reason
for Recall		The incorrect value of the International Sensitivity Index (ISI) is printed on the outer box label.
FDA Determined
Cause 2		Employee error
ActionA "Recall/Field Safety Corrective Action" letter dated 3/5/25 was mailed to consignees instructing them to stop using and discard any affected product in stock, contact their prescribing physicians/Medical Directors for evaluation for further action, and retain a copy of the notification for laboratory records. Consignees are to return the provided Response Form. Consignees with any questions are to contact their Fisher Diagnostic representative or call 800-528-0494. Distributors are to email techsupport.diagnostics.mtn@thermofisher.com with "CDR-FSN-2025-001" in the subject line to coordinate replacements.
Quantity in Commerce1,699 units
DistributionUS Distribution to: PA and OUS Foreign country of: United Arab Emirates.
Total Product Life CycleTPLC 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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = GJS
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