Recall Z-1503-2025 ยท GJS Test, Time, Prothrombin
Fisher Diagnostics
Pacific Hemostasis Thromboplastin-D, 10 ml. Used in performing one-stage prothrombin time test and factor assays.
| Date | Mar 31, 2025 (initiated Mar 6, 2025) |
| Status | Open, Classified |
| Reason | The incorrect value of the International Sensitivity Index (ISI) is printed on the outer box label. |
| Root cause | Employee error |
| 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 techsupport.diagnostics.mtn@thermofisher.com with "CDR-FSN-2025-001" in the subject line to coordina |
| Quantity | 1,699 units |
| Distribution | US Distribution to: PA and OUS Foreign country of: United Arab Emirates. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K994100 | PACIFIC HEMOSTASIS THROMBOPLASTIN D Pacific Hemostasis, Feb 18, 2000 |