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Open, Classified

Pacific Hemostasis Thromboplastin-D, 4 ml. Used in performing one-stage prothrombin time test and factor assays.

FDA Recall Z-1502-2025 · Posted 2025-03-31

Recalling FirmFisher Diagnostics
Recall StatusOpen, Classified
Product CodeGJS
Date Initiated2025-03-06
Product Quantity4,387 units

Reason for Recall

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

Firm Action

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 [email protected] with "CDR-FSN-2025-001" in the subject line to coordinate replacements.

Root Cause

Employee error

Distribution Pattern

US Distribution to: PA and OUS Foreign country of: United Arab Emirates.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K994100PACIFIC HEMOSTASIS THROMBOPLASTIN DPacific Hemostasis · 2000-02-18

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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