Recall Z-2276-2021 ยท MZA Test, Equipment, Automated Bloodborne Pathogen
Abbott Laboratories, Inc
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.
| Date | Jul 12, 2021 |
| Status | Open, Classified |
| Reason | A design defect (hardware and software) allows liquid waste pressure to build up and potentially spray users/operators. |
| Root cause | Software design |
| Action | On 07/12/2021, the firm started hand-delivering an "Product Correction Urgent-Immediate Action Required" Notification to customers informing them that the Recalling Firm has identified an issue with pressure build up in the external waste tubing of the liquid waste assembly system if obstructed leading to a potential for biohazardous exposure and/or operator injury (contact with liquid waste). Customers are instructed to follow the below instruction until the Recalling Firm can upgrade the analyzers with a future system software version and a hardware component: 1. As stated in Section 8, Haz |
| Quantity | 260 systems |
| 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, Tanzan |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.