Z-0844-2019 Class II Terminated
FDA device recall Z-0844-2019 was initiated by Ortho Clinical Diagnostics Inc on Nov 29, 2018 and is designated Class II. Reason for recall: A stability issue in the calibrators may cause calibration failures or atypical Quality Control results following a successful calibration. The recall status is terminated (terminated Feb 6, 2024). Affected quantity: 4030.
Recall Details
- Product Type
- Devices
- Report Date
- Feb 27, 2019
- Initiation Date
- Nov 29, 2018
- Termination Date
- Feb 6, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 4030
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.
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.
Code Information
Lots 1271 through 1310 (expired) Lots 1315 & Above (in-date)
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0844-2019
- openFDA file date
- Oct 21, 2026
- Loaded by RegDataLab
- Oct 23, 2026