Pacific Hemostasis Thromboplastin-D (Fisher Diagnostics) – Incorrect ISI Label (2025)
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Pacific Hemostasis Thromboplastin-D, 4 ml. Used in performing one-stage prothrombin time test and factor assays.
Brand
Fisher Diagnostics
Lot Codes / Batch Numbers
Catalog No. 100356, UDI: 00845275000542719170261130100356, Lot No. 719170, Exp. Date 11/30/26.
Products Sold
Catalog No. 100356; UDI: 00845275000542719170261130100356; Lot No. 719170; Exp. Date 11/30/26.
Fisher Diagnostics is recalling Pacific Hemostasis Thromboplastin-D, 4 ml. Used in performing one-stage prothrombin time test and fa due to The incorrect value of the International Sensitivity Index (ISI) is printed on the outer box label.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The incorrect value of the International Sensitivity Index (ISI) is printed on the outer box label.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
PA
Page updated: Jan 10, 2026