FDA recall Z-1067-2018

Diagnostica Stago, Inc. · Class II · device

Product

Neoplastine¿ Cl Plus ¿ (ref. 00375) Product Usage: Manual or automated determination of the prothrombin time (PT).

Reason for recall

Confirmed defect of homogeneity where some reagent vials will give prolonged Prothrombin Time (decreased PT%).

Distribution

Nationally

Key facts

Status: Terminated
Initiation date: 2017-10-25
Report date: 2018-03-21
Termination date: 2020-05-12
Voluntary/Mandated: Voluntary: Firm initiated
Location: Parsippany, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1067-2018