Abbott Afinion 2 Power Supply Recall for Electrostatic Discharge Risk
Abbott is recalling Afinion 2 and Alere Afinion AS100 power supplies due to a risk of electrostatic discharge and sparking that can render the unit non-functional.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text describes a functional failure (non-functional power supply) without reporting injuries, hospitalizations, or structural defects that would elevate the severity to High or Severe.
Plain-English summary
Abbott Diagnostics Technologies AS is recalling power supplies provided with the Afinion 2 and Alere Afinion AS100 analyzers. The recall affects 42,237 instruments distributed in New Jersey and various foreign countries, including Canada, Australia, and the United Kingdom. The firm name on the labels is Abbott Diagnostics Technologies AS or Alere Technologies AS, Oslo, Norway.
The recall was initiated because the analyzer system may experience electrostatic discharge and sparking of the power supply. This issue can result in the power supply becoming non-functional. All serial numbers for the affected catalog numbers are included in this recall.
Consumers and healthcare facilities should contact Abbott Diagnostics Technologies AS for instructions on how to address the affected power supplies. The source text does not specify a specific action for consumers beyond the general recall notification.
The recalled product
- 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 A
- Manufacturer
- Abbott Diagnostics Technologies AS
- Affected units
- 42,237
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All serial numbers are affected.
Distribution
Distributed in 1 state:
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