Abbott Laboratories, Inc Recall 88324
Description: Alinity s System REF 06P16-01. An automated immunoassay analyzer for In Vitro diagnostic use in blood donor screening, plasma and plasmapheresis screening, and organ donor centers, hospitals, and reference laboratories.
Abbott Laboratories, Inc Recall 88324 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-2276-2021 |
| Event ID | 88324 |
| Event Description | Alinity s System REF 06P16-01. An automated immunoassay analyzer for In Vitro diagnostic use in blood donor screening, plasma and plasmapheresis screening, and organ donor centers, hospitals, and reference laboratories. |
| Product Type | Devices |
| Distribution | Worldwide distribution. US nationwide, Australia, Bahrain, Belgium, Brazil, China, Colombia, Croatia, Egypt, Germany, Greece, Hong Kong, Hungary, Iran, Ireland, Israel, Italy, Jordan, Kuwait, Mexico, Netherlands, Pakistan, Poland, Portugal, Saudi Arabia, Serbia, Slovenia, South Africa, Spain, Tanzania, United Arab Emirates, United Kingdom, Ukraine and Zimbabwe. |
| Quantity | 260 systems |
| Recall Reason | A design defect (hardware and software) allows liquid waste pressure to build up and potentially spray users/operators. |
| Device Classification | 20210818 |
| Device Code Info | Model Number: LN 06P16-01 Serial numbers AS1001 through AS1330 |
| Center Classification Date | 20210812 |
| Recall Initiation Date | 20210712 |
| Recalling Firm | Abbott Laboratories, Inc |
| Initial Notification | Visit |
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