FDA Medical Device Recalls (openFDA)
Fisher Diagnostics: Pacific Hemostasis Thromboplastin-D, 4 ml. Used in performing one-stage prothrombin time test and factor assays.
- Recall number
- Z-1502-2025
- Recalling firm
- Fisher Diagnostics
- Product
- Pacific Hemostasis Thromboplastin-D, 4 ml. Used in performing one-stage prothrombin time test and factor assays.
- Status
- Open, Classified
- Initiated
- 2025-03-06
- Posted
- 2025-03-31
- Terminated
- not on file
- 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 coordinate replacements.
- Quantity
- 4,387 units
- Distribution
- US Distribution to: PA and OUS Foreign country of: United Arab Emirates.
- Lot, serial or model codes
- Catalog No. 100356; UDI: 00845275000542719170261130100356; Lot No. 719170; Exp. Date 11/30/26.
- 510(k) numbers
- ["K994100"]
- PMA numbers
- not on file
- Product code
- GJS
- Firm FEI
- 1181121
- Firm city
- Middletown
- Firm state
- VA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28