Recall Z-2827-2018— Tosoh Bioscience Inc
Class III · Terminated
Class III FDA medical device recall by Tosoh Bioscience Inc, initiated 2018-06-05, terminated 2020-04-03. It names 4 FDA 510(k) clearances: K121533, K111335, K981521 and 1 more. Product: 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: Distribution of unapproved product labeling.
- Recalling firm
- Tosoh Bioscience Inc
- Classification
- Class III
- Status
- Terminated
- Initiated
- 2018-06-05
- Terminated
- 2020-04-03
- Firm location
- Grove City, OH, United States
510(k) clearances named in this recall
4 on FDA's record- K121533 — ST AIA-PACK HOMOCYSTEINE; ST AIA-PACK HOMOCYSTEINE CALIBRATOR SET; AIA-PACK HOMOCYSTEINE CONTROL SET
- K111335 — ST AIA-PACK ACTH, AND ST AIA-PACK ACTH CALIBRATOR SET MODEL 025221 AND 025321
- K981521 — AIA-PACK TPOAB ASSAY
- K981522 — AIA-PACK TGAB ASSAY
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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
Data sourced from openFDA. This site is unofficial and independent of the FDA.