Recall Z-0958-2023 · DHA System, Test, Human Chorionic Gonadotropin
Abbott Laboratories
Alinity Reaction Vessels, REF: 06P1401, for use with Alinity i Systems; ARCHITECT Reaction Vessels
| Date | Jan 17, 2023 (initiated Nov 24, 2022) |
| Status | Open, Classified |
| Reason | Reaction vessels may contain a potential contaminant that could affect their optical performance. |
| Root cause | Material/Component Contamination |
| Action | On 11/24/22, the recalling firm phoned customers and informed them of the recall using a phone script. On the same day, the phone call was followed by an email that restated the information in the phone script and included a Customer Reply form. Customers were asked to discontinue use and destroy the impacted inventory according to their laboratory procedures. If customers forwarded the product to other laboratories, they were asked to inform them of this Product Recall and complete and return the Customer Reply form, which can be returned to PMS@abbott.com. The reply form asked customers t |
| Quantity | 70 cases |
| Distribution | US Distribution: IL, MN, MO, NC, ND, NJ, NY, OK, SC, TX, WV |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K170317 | Alinity i Total ß-hCG Reagent Kit, Alinity i System Abbott Laboratories, Oct 23, 2017 |