Recall Z-1502-2025— Fisher Diagnostics

Name: FDA recall Z-1502-2025
Creator: U.S. Food and Drug Administration
Published: 2025-03-06

Class II · Ongoing

Class II FDA medical device recall by Fisher Diagnostics, initiated 2025-03-06. It names one FDA 510(k) clearance: K994100. Product: Pacific Hemostasis Thromboplastin-D, 4 ml. Used in performing one-stage prothrombin time test and factor assays.. Reason: The incorrect value of the International Sensitivity Index (ISI) is printed on the outer box label..

Recalling firm: Fisher Diagnostics
Classification: Class II
Status: Ongoing
Initiated: 2025-03-06
Firm location: Middletown, VA, United States

510(k) clearances named in this recall

1 on FDA's record

K994100 — PACIFIC HEMOSTASIS THROMBOPLASTIN DPacific Hemostasis·cleared 2000-02-18

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.