i-STAT 1 Analyzer, Abbott Point of Care Inc., Abbott Park, IL 60064 USA, Product of USA. The product is intended to be u
FDA device recall Z-0812-2010 · posted 2010-02-24 · Terminated
Recall details
- Recalling firm
- Abbott Point of Care Inc.
- 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.
- 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.
- Root cause
- Labeling mix-ups
- Status
- Terminated
- Product code
- CGA
- Quantity affected
- 3,918 analyzers
- Distribution
- Worldwide Distribution (including the United States).
- Date initiated
- 2009-09-09
- Date posted
- 2010-02-24
- Date terminated
- 2014-12-08
- Location
- Princeton, NJ
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| I-STAT PORTABLE CLINICAL ANALYZER, MODEL 300 (K001387) | I-Stat Corp. | 2000-10-05 |