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
Reported: February 27, 2019 Initiated: November 29, 2018 #Z-0844-2019
Product 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 for Recall
A stability issue in the calibrators may cause calibration failures or atypical Quality Control results following a successful calibration.
Details
- Recalling Firm
- Ortho Clinical Diagnostics Inc
- Units Affected
- 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.
- Location
- Raritan, NJ
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Ortho Clinical Diagnostics Inc. Units affected: 4030.
Why was this product recalled? ▼
A stability issue in the calibrators may cause calibration failures or atypical Quality Control results following a successful calibration.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on February 27, 2019. Severity: Moderate. Recall number: Z-0844-2019.
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