Recall Z-1081-04 ยท JOX Analyzer, Heparin, Automated
Diagnostica Stago, Inc.
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
| Date | Jul 20, 2004 (initiated Dec 20, 2002) |
| Status | Terminated |
| Reason | Incorrect assay ranges on the assay value insert for Heparin Control 5. |
| Root cause | Other |
| Action | 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. |
| Quantity | 523 |
| Distribution | Diagnostica Stago shipped 523 kits to 133 US hospitals, laboratory, and clinics nationwide. There are 6 VA Hospitals. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.