Recall Z-0151-2007 ยท CGA Glucose Oxidase, Glucose
Ortho-Clinical Diagnostics
VITROS Chemistry Products GLU DT Slides GEN 56, REF (Catalog #) 153 2316, 25 slides per box. VITROS Chemistry Products GLU DT Slides quantitatively measure glucose (GLU) concentration in serum and plasma. Ortho-Clinical Diagnostics, a Johnson & Johnson company. Ortho-Clinical Diagnostics, Inc. Rochester, NY 14626. .
| Date | Nov 4, 2006 (initiated Sep 27, 2006) |
| Status | Terminated |
| Reason | Positively biased results when using the VITROS Chemistry Products GLU DT Slides GEN 56. |
| Root cause | Other |
| Action | On 9/26/06, the recalling firm notified its foreign affiliate consignees of this 'field correction', and instructed them to inform their customers who received these slides of this issue, provided them with an updated Calibration Data Module and instructed to re-calibrate these slides for continued use. On 9/27/06, all US end-use consignees were informed of this issue via Federal Express overnight letter (dated 9/27/06), and instructing them to re-calibrate these slides for continued use after they have installed the Calibration Data Module. The new CDMs were sent to all customers with VITROS |
| Quantity | 93,252 boxes (25 slides per box) in total |
| Distribution | Worldwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K841503 | KODAK EKTACHEM DT 60 ANALYZER Eastman Kodak Company, May 22, 1984 |