FDA recall Z-1068-2018

Product

STA - Neoplastine¿ Cl ¿ (ref. 00605) 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-1068-2018