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.
Reported: August 22, 2018 Initiated: June 5, 2018 #Z-2827-2018
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
Details
- Recalling Firm
- Tosoh Bioscience Inc
- Units Affected
- 9 CDS
- Distribution
- US Distribution to states of: FL, MA, MT, OK, OR and WI.
- Location
- Grove City, OH
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Tosoh Bioscience Inc. Units affected: 9 CDS.
Why was this product recalled? ▼
Distribution of unapproved product labeling
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 22, 2018. Severity: Low. Recall number: Z-2827-2018.
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