Z-2192-2020 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- June 10, 2020
- Initiation Date
- March 23, 2020
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 42,237 instruments
Product Description
Power supply provided with Afinion 2, Catalog numbers 1116553, 1116554, 1116556, 1116557, 1116597, 1116598, 1116663, 1116679, 1116680, 1116681, 1116682, 1116684, 1116770, 1116771, 1116772, 1116777, 1116778, 1116970, 1116971, 1116985, 1116986, IVD. The firm name on the label is Abbott Diagnostics Technologies AS, Oslo, Norway. Power supply provided with Alere Afinion AS100 Analyzer, Catalog numbers 1115175, 1115390, 1116049, 1116050, 1116053, 1116054, 1116456, and 1116980. The firm name on the label is Alere Technologies AS, Oslo, Norway.
Reason for Recall
The analyzer system may have an electrostatic discharge and sparking of the power supply provided with the analyzers resulting in the power supply becoming non-functional.
Distribution Pattern
Distribution was made to NJ. There was no direct government/military distribution. Foreign distribution was made to Canada, Argentina, Australia, Bangladesh, Brazil, Cambodia, Chile, China, Colombia, Denmark, Finland, France, Georgia, Germany, Guatemala, Hong Kong, Iceland, India, Italy, Ivory Coast, Japan, Korea, Madagascar, Malaysia, Mexico, Mongolia, Myanmar, The Netherlands, Norway, Oman, Pakistan, Peru, Philippines, Poland, Saudi Arabia, Singapore, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Tanzania, Thailand, Timur, Trinidad & Tobago, United Kingdom, and Zimbabwe.
Code Information
All serial numbers are affected.