Recall Z-2202-2019 ยท CGA Glucose Oxidase, Glucose
Ortho-Clinical Diagnostics
VITROS Chemistry Products GLU Slides-Product Code:1707801. IVD VITROS Chemistry Products GLU Slides quantitatively measure glucose (GLU) concentration in serum, plasma, urine, and cerebrospinal fluid using VITROS 250/350/5,1 FS/4600 Chemistry Systems and VITROS 5600/XT 7600 Integrated Systems
| Date | Jun 17, 2019 |
| Status | Terminated |
| Reason | Potentially Biased Results using VITROS Chemistry Products GLU Slides |
| Root cause | Process control |
| Action | Ortho issued On 17 June 2019, a customer letter (Ref. CL2019-172) via FedEx overnight courier and/ or ORTHO PLUS e-Communications and/ or US Postal Service Priority Mail (for PO Boxes only) to customers and distributors. The customers were notified of the issue and instructed: Discontinue using Lot 0048-0964-9287, discard any remaining inventory and switch to an alternate lot. " If you do NOT have an alternate lot, consider the following alternate options: o Use an alternate glucose method until your replacement order arrives. o Consult with your medical director to determine if the bias obser |
| Quantity | 1099 (5 pack x 60)=329700 slides |
| Distribution | US Nationwide Distribution - AL, AR, CA, CO, CT, FL, KS, KY, MA, MN, TN |
| FDA record | Open on fda.gov |