Recall Z-2328-2009 ยท CGA Glucose Oxidase, Glucose
Abbott Point of Care Inc.
Martel Printer Accessory to i-STAT Portable Clinical Analyzer, rechargeable battery pack. Printing results of clinical chemistry tests and test panels contained in the i-STAT test cartridges.
| Date | Sep 30, 2009 (initiated Apr 22, 2009) |
| Status | Terminated |
| Reason | It appears that the rechargeable battery pack is overheating with or without the presence of smoke. |
| Root cause | Nonconforming Material/Component |
| Action | Urgent Recall Notice letters dated April 2009 were sent out the third week of April by Federal Express. The letter discussed the background, required actions, and additional information. Customers are to identify all affected Martel printer rechargeable battery packs, record the number of affected packs on the attached business reply cards, and return the card along with the affected batteries as instructed. Questions should be directed to Abbott Technical Support at 800-366-8020. |
| Quantity | 2552 |
| Distribution | Worldwide Distribution |
| 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 |