Recall Z-0317-2011 ยท CHL Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
Abbott Point Of Care Inc.
i-STAT cTnl cartridge Abbott Point of Care, Princeton, NJ 08540
| Date | Nov 3, 2010 (initiated Jan 1, 2008) |
| Status | Terminated |
| Reason | i-Stat cartridges may not fill, cartridge labels or channels may appear discolored, cartridges may have fluid visible in the cartridge channel, and cartridge packaging may be distended. |
| Root cause | Other |
| Action | Abbott Point Of Care Inc.sent notification letters with a customer reply form to all affected customer in January, 2008. All distributors outside the US who were sent shipments from the affected lots were notified of the lot numbers that were affected. Affected product is to be quarantined and returned for replacement. Customers with questions about this recall can contact Abbott Point Of Care at 609 454-9000. |
| Quantity | 482,500 (total number) |
| Distribution | Worldwide Distribution: USA and Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K051433 | I-STAT CREATINE KINASE MB (CK-MB) I-Stat Corporation, Dec 15, 2005 |