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
FDA Recall Z-0844-2019 · Posted None
Recalling FirmOrtho Clinical Diagnostics Inc
Recall StatusTerminated
Product CodeJIS
Date Initiated2018-11-29
Date Terminated2024-02-06
Product Quantity4030
Reason for Recall
A stability issue in the calibrators may cause calibration failures or atypical Quality Control results following a successful calibration.
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 no later than December 14, 2018.
- Post this notification by each VITROS System at your facility that processes this assay or with the user documentation.
- Please forward this notification if the product was distributed outside of your facility.
If you have questions, please contact Ortho Care Technical Solutions Center at 1-800-421-3311.
Root Cause
Under Investigation by firm
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.