FDA Device

Neoplastine Cl Plus @ (ref.00374) Product Usage: Manual or automated determination of the prothrombin time (PT).

Hazard

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

What You Should Do

Remedy

Stago sent an Urgent Field Safety Notice letter dated October 25, 2017 to their customers. The letter identified the affected product, problem and actions to be taken: Customers were instructed to: If it is not already done, run a Quality Control test at every change of vial (if you have affected lots of product). Return to company, by fax or email, an acknowledgement form confirming that the recall letter was read by the receiving company. For questions contact the Stago Hotline (1-800-725-0607).

Products

Neoplastine Cl Plus @ (ref.00374) Product Usage: Manual or automated determination of the prothrombin time (PT).
Brand
Diagnostica Stago, Inc.
UPC
Lot 115080 (Exp: 01-2018) Lot 251241 (Exp: 01-2018)

Units Affected

1636 Kits