Recall Z-2192-2020
Abbott Diagnostics Technologies AS · initiated March 23, 2020
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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.
Codes / lots: All serial numbers are affected.
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.
FDA-determined cause: Device Design
Action taken
The recalling firm/manufacturer issued medical device correction letters dated 3/23/2020 on 3/23/2020 to their direct distributors requesting end user customer information. The recalling firm/manufacturer issued medical device correction letters to the end users dated 3/31/2020 via a third-party notification firm. The notification informed the end user of the issue and requested to be notified of the number of power supplies needed for replacement. The affected power supplies were to be discarded by the end user.
Details
- Recall number
- Z-2192-2020
- Initiated
- March 23, 2020
- Product code
- PDJ – Hemoglobin A1c Test System
- Quantity
- 42,237 instruments
- Distribution
- 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…
- Recalling firm
- Abbott Diagnostics Technologies AS, Oslo