Fisher Diagnostics recalls Pacific Hemostasis Thromboplastin-D

The incorrect value of the International Sensitivity Index (ISI) is printed on the outer box label.

Pacific Hemostasis Thromboplastin-D, 10 ml. Used in performing one-stage prothrombin time test and factor assays.

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.

• FDA enforcement recordOfficial FDA database entry for Z-1503-2025
• FDA 510(k) clearance · K994100The device's official FDA premarket clearance record
• FDA device classification · GJSOfficial FDA classification for this device type
• CFR regulation · 21 CFR 864.7750The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Fisher DiagnosticsSearch for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.