Diagnostica Stago, Inc. Recalls
FDA
Showing 21-22 of 22 recalls
STA Heparin Control kit used on STA analyzers (STA, STA Compact, STAR). The STA heparin control kit is a set of two plasmas containing different levels of unfractionated heparin (UFH) intended for the quality control of UFH assays performed on STA analyzers. Each kit contains 6 x 1 mL vials of Reagent 1 (STA Heparin Control 2) and 6 x 1 mL of Reagent 2 (STA Heparin Control 5) packaged in a white cardboard unit container. Distributed in the USA by : Diagnostica Stago, Inc, Five Century Drive,
Incorrect assay ranges on the assay value insert for Heparin Control 5.
Manufacturer notified Diagnostica Stago, US of the problem in December 2002. Diagnostica Stago sent a letter dated 12/20/2002 along with replacement insert sheet and effectiveness check forms to all consignees.
STA-Compact Hemostasis System with Cap piercing capability.
With maintenance of the STA line, the cap-piercing feature may involve potential risk of needle puncture injury.
The firm sent out letters on March 5, 2003 to their customers alerting them to the problem and providing further guidance on how to prevent the problem. The firm will be sending out to the customers a protective device to attach to the needle assembly as soon as possible