i-STAT 1 Analyzer, Abbott Point of Care Inc., Abbott Park, IL 60064 USA, Product of USA. The product is intended to be used by trained medical professionals for use with i-STAT test cartridges and MediSense blood glucose test strips. i-STAT cartridges comprise a variety of clinical chemistry tests and test panels.
This recall has been terminated (originally issued February 24, 2010).
- Company
- Abbott Point Of Care Inc.
- Recall Initiated
- September 9, 2009
- Posted
- February 24, 2010
- Terminated
- December 8, 2014
- Recall Number
- Z-0812-2010
- Quantity
- 3,918 analyzers
- Firm Location
- Princeton, NJ
- Official Source
- View on FDA website ↗
Reason for Recall
The storage temperature on the label on the side of the i-Stat Portable Clinical Analyzer shipping box does not match product specification.
Distribution
Worldwide Distribution (including the United States).
Lot / Code Info
Catalog number 06F16-10.
Root Cause
Labeling mix-ups
Action Taken
An "Urgent Recall Notice" was issued to customers during September 2009. The letter described the affected product, issue and recommended actions. Customers were asked to verify storage conditions on the box are correct and if not, discard the outside box. If the customer requires a replacement box, the customer must contact Abbott Point of Care Technical Support. Direct questions and requests for additional information to the Abbott Point of Care Technical Support by calling 1-800-366-8020, Option 1 or contact your Abbott Point of Care representative.