Tosoh Bioscience Inc: Medical Device Recall in 2018 - (Recall #: Z-2827-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

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.

Product Classification:

Class III

Date Initiated: June 5, 2018

Date Posted: August 22, 2018

Recall Number: Z-2827-2018

Event ID: 80482

Reason for Recall:

Distribution of unapproved product labeling

Status: Terminated

Product Quantity: 9 CDS

Code Information:

rev: 6.0-040418

Distribution Pattern:

US Distribution to states of: FL, MA, MT, OK, OR and WI.

Voluntary or Mandated:

Voluntary: Firm initiated