Z-1503-2025Class II

Pacific Hemostasis Thromboplastin-D, 10 ml. Used in performing one-stage prothrombin time test and factor...

Name: Z-1503-2025 Pacific Hemostasis Thromboplastin-D, 10 ml. Used in performing one-stage prothrombin time test and factor...
Creator: Fisher Diagnostics
Published: 2025-03-06
License: https://open.fda.gov/license/

Fisher Diagnostics / initiated 2025-03-06 / Open, Classified / root cause: manufacturing process

FDA source

Fisher Diagnostics began a recall of Pacific Hemostasis Thromboplastin-D, 10 ml. Used in performing one-stage prothrombin time test and factor assays on 2025-03-06. FDA classified it as Class II and gives the reason as "The incorrect value of the International Sensitivity Index (ISI) is printed on the outer box label". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1503-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-03-06
Posted: 2025-03-31
Recalling firm: Fisher Diagnostics
Product: Pacific Hemostasis Thromboplastin-D, 10 ml. Used in performing one-stage prothrombin time test and factor assays.
Product code: GJS Test, Time, Prothrombin
Reason for recall: The incorrect value of the International Sensitivity Index (ISI) is printed on the outer box label.
Root cause tag: manufacturing process
FDA 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 [email protected] with "CDR-FSN-2025-001" in the subject line to coordinate replacements.
Quantity in commerce: 1,699 units
Distribution: US Distribution to: PA and OUS Foreign country of: United Arab Emirates.
Product codes and lots: Catalog No. 100357; UDI: 00845275000798665150270131100357; Lot No. 665150; Exp. Date 01/31/2027.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1503-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1502-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-04-09	2025-03-31
Z-1503-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-04-09	2025-03-31

Product code GJS

K994100Class IIPacific Hemostasis Thromboplastin DPacific Hemostasis / cleared 2000-02-18

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)