Pacific Hemostasis Thromboplastin-D recall
Pacific Hemostasis Thromboplastin-D, 10 ml. Used in performing one-stage prothrombin time test and factor assays.
Why was Pacific Hemostasis Thromboplastin-D recalled?
The incorrect value of the International Sensitivity Index (ISI) is printed on the outer box label.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Catalog No. 100357; UDI: 00845275000798665150270131100357; Lot No. 665150; Exp. Date 01/31/2027.
- Product
- Pacific Hemostasis Thromboplastin-D, 10 ml. Used in performing one-stage prothrombin time test and factor assays.
- Recalling firm
- Fisher Diagnostics
- Quantity
- 1,699 units
- Distribution
- US Distribution to: PA and OUS Foreign country of: United Arab Emirates.
- Recall date
- April 9, 2025
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)