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.
FDA Recall Z-2827-2018 · Posted None
Recalling FirmTosoh Bioscience Inc
Recall StatusTerminated
Product CodeJIX
Date Initiated2018-06-05
Date Terminated2020-04-03
Product Quantity9 CDS
Reason for Recall
Distribution of unapproved product labeling
Firm Action
The firm, Tosoh Bioscience, notified customers via a phone call on May 29, 2018 and May 31, 2018, reference "Product Labeling-Removal". The phone call described the product, problem and actions to be taken. The firm instructed to confirm receipt of the CD containing AAMs; return the unapproved labeling; if printouts were made of any information on the CD then destroy it, if not, thank customer for response and complete the Customer Call form.
The firm will provide the Customers updated CD following approval and release.
Any further questions, contact Sr. QA Manager at 614-317-1909 or email: [email protected].
Root Cause
Error in labeling
Distribution Pattern
US Distribution to states of: FL, MA, MT, OK, OR and WI.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
K121533ST AIA-PACK HOMOCYSTEINE; ST AIA-PACK HOMOCYSTEINE CALIBRATOR SET; AIA-PACK HOMOCYSTEINE CONTROL SETTosoh Bioscience, Inc. · 2012-06-15K111335ST AIA-PACK ACTH, AND ST AIA-PACK ACTH CALIBRATOR SET MODEL 025221 AND 025321Tosoh Bioscience, Inc. · 2011-12-01K981521AIA-PACK TPOAB ASSAYTosoh Medics, Inc. · 1998-10-08K981522AIA-PACK TGAB ASSAYTosoh Medics, Inc. · 1998-10-08
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.