Recall Z-1976-2012 ยท CHL Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
Abbott Point Of Care Inc.
i-STAT1 Abaxis Analyzer; Abbott Point of Care, Princeton, NJ 08540
| Date | Jul 9, 2012 (initiated Sep 8, 2011) |
| Status | Terminated |
| Reason | Some i-Stat Analyzers become uncomfortably hot to touch in the are of the battery. This is a recall extension. |
| Root cause | Device Design |
| Action | Abbott Point Care sent an Urgent Product Recall letter dated September 2011 to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to confirm the number of affected product at their facility that were using the Old Battery Carrier. Fill out the affected Buesiness Reply Card and submit their facility information as per the instructions on the card. Upon the receipt of the New Battery Carriers, replace the Old Battery Center with the New Battery Center. Customers were instructed to immediately dispose |
| Quantity | 6000-0000-650 units |
| Distribution | Worldwide Distribution - USA (nationwide) |
| 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 |