FDA Enforcement
Class II
Terminated
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
Recall: Z-0844-2019
·
Reported February 27, 2019
Enforcement
- Recall Number
- Z-0844-2019
- Event ID
- 81767
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Ortho Clinical Diagnostics Inc
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- February 27, 2019
- Initiation Date
- November 29, 2018
- Classification Date
- February 15, 2019
- Termination Date
- February 6, 2024
- Address
- 1001 US Highway 202, Raritan, NJ, 08869-1424, United States
Description
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
Reason
A stability issue in the calibrators may cause calibration failures or atypical Quality Control results following a successful calibration.
Code Info
Lots 1271 through 1310 (expired) Lots 1315 & Above (in-date)
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.
Quantity
4030