Recall Z-0812-2010 ยท CGA Glucose Oxidase, Glucose
Abbott Point of Care Inc.
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.
| Date | Feb 24, 2010 (initiated Sep 9, 2009) |
| Status | Terminated |
| Reason | The storage temperature on the label on the side of the i-Stat Portable Clinical Analyzer shipping box does not match product specification. |
| Root cause | Labeling mix-ups |
| Action | 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. |
| Quantity | 3,918 analyzers |
| Distribution | Worldwide Distribution (including the United States). |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K001387 | I-STAT PORTABLE CLINICAL ANALYZER, MODEL 300 I-Stat Corp., Oct 5, 2000 |