Recall Z-1792-2010 ยท JPI Device, Hematocrit Measuring
Abbott Point of Care Inc.
i-STAT CG8+ cartridges The i-stat Hematocrit (Hct) is intended for use in the in vitro quantification of packed red blood cell volume in arterial, venous, or capillary whole blood. Hematocrit is a key indicator of the body's state of hydration, anemia, or severe blood loss, as well as the blood's ability to transport oxygen.
| Date | Jun 11, 2010 (initiated Feb 5, 2010) |
| Status | Terminated |
| Reason | Abbott has determined that there is a dependence of the i-STAT Hct assay on the vertical pitch angle of the i-STAT Analyzer during the blood analysis cycle. |
| Root cause | Other |
| Action | The firm, Abbott Point of Care, sent an "Urgent Field Safety Notice Product Recall" letter dated January 2010 to the customers. Safety Alert /Product Recall letters were also sent by Federal Express commencing on February 5, 2010. The letter describes the product, problem and the action to be taken by the customers. The customers were instructed to replace the i-STAT Hematocrit/HCT and Calculated Hemoglobin/HB /Cartridge and Test Information (CT) Sheet found in their i-STAT System manual with those included in the mailing , and to provide a copy of the letter another facility, if they have for |
| Quantity | 40,446 cartridges, all varieties |
| Distribution | Worldwide distribution: USA and Argentina; Austria; Bahamas; Bolivia; Brazil; Chile; Hong Kong; China; China; Columbia; Costa Rica; Denmark; Dominican Republic; Ecuador; El Salvador; Finland; Georgia; Greece; Honduras; India; India; Ireland; Israel; Italy; Japan; Kuwait; Mauritius; Mexico; Norway; O |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K040918 | WAKO LIPID CONTROL, LEVEL 1 AND LEVEL 2 Wako Chemicals USA, Inc., May 17, 2004 |