Pacific Hemostasis Thromboplastin-D, 4 ml. Used in performing one-stage prothrombin time test and factor assays.
This recall is currently active, issued March 31, 2025. It was issued by Fisher Diagnostics.
- Company
- Fisher Diagnostics
- Recall Initiated
- March 6, 2025
- Posted
- March 31, 2025
- Recall Number
- Z-1502-2025
- Quantity
- 4,387 units
- Firm Location
- Middletown, VA
- Official Source
- View on FDA website ↗
Reason for Recall
The incorrect value of the International Sensitivity Index (ISI) is printed on the outer box label.
Distribution
US Distribution to: PA and OUS Foreign country of: United Arab Emirates.
Lot / Code Info
Catalog No. 100356; UDI: 00845275000542719170261130100356; Lot No. 719170; Exp. Date 11/30/26.
Root Cause
Employee error
Action Taken
A "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.