Reported Jun 10, 2020 · Ongoing
Power supply provided with Afinion 2, Catalog numbers 1116553, 1116554, 1116556, 1116557, 1116597, 1116598, 1116663,…
Abbott Diagnostics Technologies AS
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Abbott Diagnostics Technologies AS · Kjelsaasveien 161 · Oslo, N/A · N/A
Is this the product you have?
- 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.
- Lot codes and dates
- All serial numbers are affected.
- Amount recalled
- 42,237 instruments
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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