FDA recall Z-1502-2025

Fisher Diagnostics · Class II · device

Product

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

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

Key facts

Status
Ongoing
Initiation date
2025-03-06
Report date
2025-04-09
Voluntary/Mandated
Voluntary: Firm initiated
Location
Middletown, VA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1502-2025