Z-2981-2020 Class II Terminated
FDA device recall Z-2981-2020 was initiated by Roche Diagnostics Operations, Inc. on August 20, 2020 and is designated Class II. Reason for recall: 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. The recall status is terminated (terminated October 22, 2021). Affected quantity: 11,870 reagent kits.
Recall Details
- Product Type
- Devices
- Report Date
- September 23, 2020
- Initiation Date
- August 20, 2020
- Termination Date
- October 22, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 11,870 reagent kits
Product Description
Elecsys Anti-TPO Assay on cobas e analyzers 411, 601, 602, Catalog Number 06368590190
Reason for Recall
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.
Distribution Pattern
US Nationwide
Code Information
All current and upcoming lots