VITROS 3600 Immunodiagnostic System recall: Software Issue
VITROS 3600 Immunodiagnostic System, Catalog Number 6802783,for use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a…
Why was VITROS 3600 Immunodiagnostic System recalled?
Ortho Clinical Diagnostics confirmed a software timing anomaly in which the VITROS 3600 and 5600 Systems may unexpectedly aspirate from or dispense into an unintended sample that may lead to erroneous or contaminated results.
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?
Software Version 3.2.2 & below; Serial Numbers J36000012 - J36000933.Unique Device Identifier No. 10758750002979, IVD.
- Product
- VITROS 3600 Immunodiagnostic System, Catalog Number 6802783,for use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a…
- Recalling firm
- Ortho-Clinical Diagnostics
- Quantity
- US: 218 units, Foreign: 587 units
- Distribution
- Nationwide, Puerto Rico and Foreign distribution to the following countries: Australia, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Mexico, Panama, Singapore, Spain, and Venezuela.
- Recall date
- June 15, 2016
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)