Recall Z-2192-2020 ยท PDJ Hemoglobin A1c Test System
Abbott Diagnostics Technologies AS
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 numbe
| Date | Mar 23, 2020 |
| Status | Open, Classified |
| 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. |
| Root cause | Device Design |
| Action | 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. |
| 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 Coa |
| FDA record | Open on fda.gov |