Z-0645-2017 Class II Terminated
FDA device recall Z-0645-2017 was initiated by Diasorin Inc. on July 13, 2016 and is designated Class II. Reason for recall: DiaSorin is issuing an urgent medical device correction for the LIAISON¿ Estradiol II Gen assay. Due to the risk of a recently identified cross reactivity, the LIAISON¿ Estradiol II Gena assay should … The recall status is terminated (terminated December 27, 2017). Affected quantity: 10,739.
Recall Details
- Product Type
- Devices
- Report Date
- November 30, 2016
- Initiation Date
- July 13, 2016
- Termination Date
- December 27, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 10,739
Product Description
Reason for Recall
Distribution Pattern
USA (nationwide) Distribution and Worldwide Distribution including the states of : AR, AZ, CA, FL, ID, NJ, NV, NY and PA.., and to the countries of : Saudi Arabia, Colombia, Mauritius, Iraq, Mongolia, Greece, Albania, Austria, Bosnia, Bosnia Herzegovina, Belarus, Bulgaria, Macedonia, Poland, Serbia, Dominican Rep., Tunisia, Paraguay, Hungary, Jordan, Egypt, Belgium, Caribbean, Germany, Brazil, Mexico, Italy, India, South Korea, Cyprus, Bangladesh, Morocco, Chile, Bahrain, Palestine, Utd.Arab.Emir., Kosovo, Uruguay, Venezuela, Hungary, Australia, Vietnam, Sri Lanka, Turkey, Vietnam, Romania, Mauritius, Ecuador, Lebanon, Nepal, Argentina, Hong Kong, China and Canada.