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Recall Observatory FDA recall evidence

Device product

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.

Z-2192-2020

March 23, 2020

Class II

Product summary

Firm
Abbott Diagnostics Technologies AS
Event
Event 85313
Status
Ongoing
Classification
Class II
Quantity
42,237 instruments
Official record key
device-enforcement:Z-2192-2020

Official wording

Reason: 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.

Code information: All serial numbers are affected.

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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.