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U.S. Department of Health and Human Services

Class 3 Device Recall Tosoh Bioscience

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 Class 3 Device Recall Tosoh Biosciencesee related information
Date Initiated by FirmJune 05, 2018
Create DateAugust 15, 2018
Recall Status1 Terminated 3 on April 03, 2020
Recall NumberZ-2827-2018
Recall Event ID 80482
510(K)NumberK111335 K121533 K981521 K981522 
Product Classification Calibrator, multi-analyte mixture - Product Code JIX
ProductTosoh 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.
Code Information rev: 6.0-040418
Recalling Firm/
Manufacturer		 Tosoh Bioscience Inc
3600 Gantz Rd
Grove City OH 43123-1895
For Additional Information Contact
614-317-1909
Manufacturer Reason
for Recall		Distribution of unapproved product labeling
FDA Determined
Cause 2		Error in labeling
ActionThe 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: Levent.durukan@tosoh.com.
Quantity in Commerce9 CDS
DistributionUS Distribution to states of: FL, MA, MT, OK, OR and WI.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = JIX
510(K)s with Product Code = JIX
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