Recall Z-1503-2025
Fisher Diagnostics · initiated March 6, 2025
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Pacific Hemostasis Thromboplastin-D, 10 ml. Used in performing one-stage prothrombin time test and factor assays.
Codes / lots: Catalog No. 100357; UDI: 00845275000798665150270131100357; Lot No. 665150; Exp. Date 01/31/2027.
Reason for recall
The incorrect value of the International Sensitivity Index (ISI) is printed on the outer box label.
FDA-determined cause: Employee error
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.
Details
- Recall number
- Z-1503-2025
- Initiated
- March 6, 2025
- Posted by FDA
- March 31, 2025
- Product code
- GJS – Test, Time, Prothrombin
- Quantity
- 1,699 units
- Distribution
- US Distribution to: PA and OUS Foreign country of: United Arab Emirates.
- Recalling firm
- Fisher Diagnostics, Middletown, VA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1502-2025 Class II | Pacific Hemostasis Thromboplastin-D, 4 ml. Used in performing one-stage prothrombin time…The incorrect value of the International Sensitivity Index (ISI) is printed on the outer box label. | 03/06/2025Open, Classified |