VITROS¿ ECi/ECiQ Immunodiagnostic System recall
VITROS¿ ECi/ECiQ Immunodiagnostic System Product Code: 1922814 For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of…
Why was VITROS¿ ECi/ECiQ Immunodiagnostic System recalled?
Luminometer Malfunction May Cause Inability to Process MicroWell Assays on VITROS¿ Systems
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?
Serial Numbers: 30005946, 30005947, 30005948, 30005960 through 30005975, 30005979 30005981 through 30005991 30005993, 30005994 30006000 through 30006005 UDI: 10758750000272
- Product
- VITROS¿ ECi/ECiQ Immunodiagnostic System Product Code: 1922814 For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of…
- Recalling firm
- Ortho-Clinical Diagnostics
- Quantity
- 45 units
- Distribution
- Worldwide Distribution: US (Nationwide) and countries of: Australia, Belgium, Brazil, Canada, Chile, China, Colombia, Denmark, France, Germany, India, Italy, Japan, Mexico, Norway, Poland, Portugal, Russia, Singapore, Spain, Sweden,The Netherlands, and United Kingdom.
- Recall date
- May 15, 2019
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)