STA Heparin Control kit used on STA analyzers (STA, STA Compact, STAR). The STA heparin control kit is a set of two plas
FDA device recall Z-1081-04 · posted 2004-07-20 · Terminated
Recall details
- Recalling firm
- Diagnostica Stago, Inc.
- Reason for recall
- Incorrect assay ranges on the assay value insert for Heparin Control 5.
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- JOX
- Quantity affected
- 523
- Distribution
- Diagnostica Stago shipped 523 kits to 133 US hospitals, laboratory, and clinics nationwide. There are 6 VA Hospitals.
- Date initiated
- 2002-12-20
- Date posted
- 2004-07-20
- Date terminated
- 2004-07-14
- Location
- Parsippany, NJ
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