Recall Z-0597-2011 ยท CGA Glucose Oxidase, Glucose
Abbott Point Of Care Inc.
i-STAT Portable Clinical Analyzer; Abbott Point of Care, Princeton, NJ 08540 Model 200. The 37 degree 37 degree C tests for sodium, potassium, ionized calcium, hematocrit, pH, PCO2, PO2 and the i-stat portable analyzer as part of the i-STAT system, are intended for use in the in vitro quantization of arterial, venous or capillary whole blood.
| Date | Dec 10, 2010 (initiated Sep 20, 2010) |
| Status | Terminated |
| Reason | i-STAT Analyzers batteries may overheat due to a circuitry failure, resulting in the analyzer becoming uncomfortably hot in the area of the battery component. |
| Root cause | Other |
| Action | Abbott Point of Care issued Urgent Recall Notice letters dated September 20, 2010 to customers. The letter informs users to of the possibility of the unit becoming hot to touch, to remove the unit if this is the case, not to remove batteries unless instructed to do by APOC and to forward notification of the recall to customers if it has been further distributed. Abbott Point of Care can be contacted at 800 366-8020, option 1, about this action. Recall extended in May 2011 to included distribution dates of 9/20/2010-6/6/2011. |
| Quantity | 06F16-02- 1295: 210000 - 1076; 210001 - 447; 210002 - 5339; 210003 - 9051. |
| Distribution | Worldwide Distrbution: Throughout USA and the countries of Argentina, Australia, Austria, Belgium.Bolivia, Bosnia-Herz, Canada. Croatia, Chile, Colombia, Costa Rica, Denmark, Ecuador, El Salvador, Finland, Georgian Republic, Greece, Honduras, France, Germany, Italy, Netherlands, New Zealand, Hong Ko |
| 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 |