Home / Recalls / Fisher Diagnostics / Z-1502-2025

Z-1502-2025 Class II Ongoing

Recalled by Fisher Diagnostics — Middletown, VA

Recall Details

Product Type
Devices
Report Date
April 9, 2025
Initiation Date
March 6, 2025
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
4,387 units

Product Description

Pacific Hemostasis Thromboplastin-D, 4 ml. Used in performing one-stage prothrombin time test and factor assays.

Reason for Recall

The incorrect value of the International Sensitivity Index (ISI) is printed on the outer box label.

Distribution Pattern

US Distribution to: PA and OUS Foreign country of: United Arab Emirates.

Code Information

Catalog No. 100356; UDI: 00845275000542719170261130100356; Lot No. 719170; Exp. Date 11/30/26.

Other recalls by Fisher Diagnostics

  • Z-1503-2025 Class II — Pacific Hemostasis Thromboplastin-D, 10 ml. Used in performing one-stage prothro (March 6, 2025)
  • Z-2762-2017 Class II — Pacific Hemostasis FDP (Fibrinogen Degradation Products) Assay Kit (30 Determina (May 19, 2017)
  • Z-2763-2017 Class II — Pacific Hemostasis FDP Latex Reagent, REF/Model Number 100651, UDI 0084527500087 (May 19, 2017)