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, Parsippany, NJ 07054, Lot 02019***.
- Company
- Diagnostica Stago, Inc.
- Recall Initiated
- December 20, 2002
- Posted
- July 20, 2004
- Terminated
- July 14, 2004
- Recall Number
- Z-1081-04
- Quantity
- 523
- Firm Location
- Parsippany, NJ
Reason for Recall
Incorrect assay ranges on the assay value insert for Heparin Control 5.
Distribution
Diagnostica Stago shipped 523 kits to 133 US hospitals, laboratory, and clinics nationwide. There are 6 VA Hospitals.
Lot / Code Info
Lot number 02019. Exp. 1/31/2004.
Root Cause
Other
Action Taken
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.
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