Recall Z-3304-2024 ยท JZO System, Test, Thyroid Autoantibody
Siemens Healthcare Diagnostics, Inc.
ADVIA Centaur aTPO Assay, Material Number 10630886 (100 Test) and 10630887 (500 Test)
| Date | Sep 27, 2024 (initiated Aug 21, 2024) |
| Status | Open, Classified |
| Reason | Positive bias in patient results at and below the cut-off of 60 U/mL with the lots listed in the table below when compared to alternate lots on the Atellica IM analyzer. |
| Root cause | Under Investigation by firm |
| Action | An Urgent Medical Device Correction notification letter dated 8/21/24 was sent to customers. Customer Actions " Please review this letter with your Medical Director to determine the appropriate course of action, including for any previously generated results, if applicable. " Perform the actions provided below: o Discontinue use of and discard the kit lots listed in the table above (Products Section). o You may request no-charge replacement product from your local Siemens Healthineers or distributor office. Please review your inventory of these products to determine your laboratory s replacem |
| Quantity | 5622 kits |
| Distribution | Worldwide distribution - US Nationwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K003291 | BAYER DIAGNOSTICS ACS:180 AND ADVIA CENTAUR ANTI-TPO ASSAY Bayer Diagnostics Corp., Dec 5, 2000 |