Pacific Hemostasis Thromboplastin-D, 10 ml. Used in performing one-stage prothrombin time test and factor assays.
FDA device recall Z-1503-2025 · posted 2025-03-31 · Open, Classified
Recall details
- Recalling firm
- Fisher Diagnostics
- Reason for recall
- The incorrect value of the International Sensitivity Index (ISI) is printed on the outer box label.
- 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.
- Root cause
- Employee error
- Status
- Open, Classified
- Product code
- GJS
- Quantity affected
- 1,699 units
- Distribution
- US Distribution to: PA and OUS Foreign country of: United Arab Emirates.
- Date initiated
- 2025-03-06
- Date posted
- 2025-03-31
- Location
- Middletown, VA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| PACIFIC HEMOSTASIS THROMBOPLASTIN D (K994100) | Pacific Hemostasis | 2000-02-18 |