Recall Z-0844-2019 ยท JIS Calibrator, Primary
Ortho Clinical Diagnostics Inc
Vitros Myoglobin Calibrators, Product Code 6801043 For use in the calibration of the VITROS ECi/ECiQ Immunodiagnostic Systems, the VITROS 3600 Immunodiagnostic System and the VITROS 5600 Integrated System for the quantitative measurement of myoglobin in human serum and plasma
| Date | Nov 29, 2018 |
| Status | Terminated |
| Reason | A stability issue in the calibrators may cause calibration failures or atypical Quality Control results following a successful calibration. |
| Root cause | Under Investigation by firm |
| Action | On November 29, 2018, the firm sent a customer letter all affected customers. All consignees were notified of the issue and informed of revised instructions for VITROS Myoglobin Calibrators: - Reconstitute the calibrators using 1.0 mL distilled water, as per current instructions. - Allow reconstituted calibrator vials to stand at room temperature for 2 hours and then proceed with calibration within 2 hours (4 hours total) - Discard reconstituted calibrators after 4 hours. - Acknowledge the information contained in this notification by completing and submitting the Confirmation of Receipt form |
| Quantity | 4030 |
| Distribution | Distributed nationwide domestically. Foreign distribution to Australia, Brazil, Canada, Chile, China, Colombia, India, Japan, Mexico, Singapore, UK, France, Germany, Italy, Spain, Portugal, Poland, Russia, Denmark, Norway, Sweden, Belgium, and the Netherlands. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K033300 | VITROS IMMUNODIAGNOSTIC PRODUCTS MYOGLOBIN REAGENT PACK; CALIBRATORS; RANGE VERIFIERS Ortho-Clinical Diagnostics, Inc., Nov 5, 2003 |