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U.S. Department of Health and Human Services

Class 2 Device Recall Thyroglobulin Antibody (TgAb) Calibrator Set

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  Class 2 Device Recall Thyroglobulin Antibody (TgAb) Calibrator Set see related information
Date Initiated by Firm February 23, 2012
Create Date March 08, 2021
Recall Status1 Terminated 3 on July 08, 2021
Recall Number Z-1187-2021
Recall Event ID 76372
510(K)Number K981522  
Product Classification System, test, thyroid autoantibody - Product Code JZO
Product Thyroglobulin Antibody (TgAB) Calibrator - Product Usage: intended for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of anti-thyroglobulin antibodies (TgAb) in human serum on specific TOSOH AIA System analyzers. Measurements obtained by this device aid in the diagnosis of autoimmune thyroid disorders, such as Graves disease and Hashimotos disease. Comment to IU: Please note that the Calibrator set is not part of the IU but required for the assay.
Code Information Part Number 020391; Lot # B834868, Lot # BX34869, Lot # C234871, Lot # C434872 & Lot # C534873.
Recalling Firm/
Manufacturer		 Tosoh Bioscience Inc
3600 Gantz Rd
Grove City OH 43123-1895
For Additional Information Contact Mrs. Susan (NMI) Koss
614-317-1909
Manufacturer Reason
for Recall		 Some combinations of Calibrator lots and AlA PACKS resulted in Calibrator #6 not giving a value, making the calibration unacceptable.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action On 7/24/2012 the firm sent recall notificaiton letters to their customers.
Quantity in Commerce 34 boxess/2 sets/6 bottles
Distribution US Nationwide distribution in the states of CA, FL, GA, NY, OH & OR.
Total Product Life Cycle TPLC 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) Database 510(K)s with Product Code = JZO and Original Applicant = TOSOH MEDICS, INC.
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