Z-2827-2018 Class III Terminated
FDA device recall Z-2827-2018 was initiated by Tosoh Bioscience Inc on Jun 5, 2018 and is designated Class III. Reason for recall: Distribution of unapproved product labeling The recall status is terminated (terminated Apr 3, 2020). Affected quantity: 9 CDS.
Recall Details
- Product Type
- Devices
- Report Date
- Aug 22, 2018
- Initiation Date
- Jun 5, 2018
- Termination Date
- Apr 3, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 9 CDS
Product Description
Tosoh Bioscience AIA Analyte Application Manual (AAM) CD Part Number: 997027 CD contains analyte application manuals for 47 analyte reagent packs for use with the Tosoh AIA (Automated Immuno-Assay) family of analyzers. Each analyte application manual includes a reference section on assay controls in the analyte application manual.
Reason for Recall
Distribution of unapproved product labeling
Distribution Pattern
US Distribution to states of: FL, MA, MT, OK, OR and WI.
Code Information
rev: 6.0-040418
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2827-2018
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026