Vitros Myoglobin Calibrators recall
Vitros Myoglobin Calibrators, Product Code 6801043 For use in the calibration of the VITROS ECi/ECiQ Immunodiagnostic Systems, the VITROS 3600…
Why was Vitros Myoglobin Calibrators recalled?
A stability issue in the calibrators may cause calibration failures or atypical Quality Control results following a successful calibration.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lots 1271 through 1310 (expired) Lots 1315 & Above (in-date)
- Product
- Vitros Myoglobin Calibrators, Product Code 6801043 For use in the calibration of the VITROS ECi/ECiQ Immunodiagnostic Systems, the VITROS 3600…
- Recalling firm
- Ortho Clinical Diagnostics Inc
- 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.
- Recall date
- February 27, 2019
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)