Recall Z-1224-03 ยท CGA Glucose Oxidase, Glucose
Ortho-Clinical Diagnostics
Vitros Chemistry *** GLU (glucose) Slides *** 5 cartridges each containing 60 slides for a total of 300 tests per box *** REF 170 7801 *** Ortho-Clinical Diagnostics Inc., 100 Indigo Creek Drive, Rochester, NY 14626. [NOTE: product has an 18 month shelf life.]
| Date | Sep 11, 2003 (initiated Jul 28, 2003) |
| Status | Terminated |
| Reason | Results of glucose measurements on sodium fluoride/potassium oxalate specimens can be negatively biased when using Vitros GLU and GLU DT slides stored in the refrigerator. GLU slides are processed by high volume chemistry systems typically used in hospital laboratories. |
| Root cause | Other |
| Action | GLU Slides: Letters dated between 7/28/03 and 8/11/03 provide revised storage instructions. Customers using NaF/KOx blood collection tubes and have VITROS GLU slides that have been refrigerated for more than four months will receive replacement product. Those customers are instructed to continue to use the slides only until replacement product arrives. GLU DT Slides: Letters dated between 7/28/03 and 8/11/03 with the same instructions as for GLU slides. |
| Quantity | 487,912 boxes |
| Distribution | Nationwide and worldwide distribution to distributors and end-users. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K955286 | EKTACHEM CLINICAL CHEMISTRY SLIDE GLUCOSE (GLU) Johnson & Johnson Clinical Diagnostics, Inc., May 17, 1996 |