Recall Z-2981-2020 ยท JZO System, Test, Thyroid Autoantibody
Roche Diagnostics Operations, Inc.
Elecsys Anti-TPO Assay on cobas e analyzers 411, 601, 602, Catalog Number 06368590190
| Date | Aug 20, 2020 |
| Status | Terminated |
| Reason | Recent internal verification studies found the current RF interference claim to no longer be met for the assay on the cobas e 411, 601, and 602 analyzers. Therefore, the claim has been updated. |
| Root cause | Nonconforming Material/Component |
| Action | Urgent Medical Device Correction notification letters dated 8/20/20 were distributed to customers. Actions Required " Be aware of the new RF interference claims listed in this Urgent Medical Device Correction (UMDC). This UMDC serves as labeling until the updated method sheet (V3), anticipated in September 2020, is available. " Please consult with the physician or pathologist at your facility to determine specific clinical implications for your patients. Customers do not need to perform an additional RF test unless otherwise determined in consultation with the physician or pathologist at your |
| Quantity | 11,870 reagent kits |
| Distribution | US Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K051890 | ROCHE DIAGNOSTICS COBAS ELECSYS ANTI-TPO Roche Diagnostics Corp., Aug 4, 2005 |