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U.S. Department of Health and Human Services

Class 3 Device Recall Randox SEROLOGY ToRCH lgM

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  Class 3 Device Recall Randox SEROLOGY ToRCH lgM see related information
Date Initiated by Firm November 06, 2023
Date Posted January 02, 2024
Recall Status1 Open3, Classified
Recall Number Z-0624-2024
Recall Event ID 93543
Product Classification Multi-analyte controls unassayed - Product Code OHQ
Product SEROLOGY ToRCH lgM 2022 POSITIVE CONTROLI Intended for use with in vitro assays for determination of IgM antibodies to Cytomegalovirus (CMV), IgM antibodies to Rubella Virus, IgM antibodies to Toxoplasma gondii, IgM antibodies to Herpes Simplex Virus Type 1 and 2.
Catalog Number: SR10349
Code Information GTIN: 05055273216424 Bath/Lot Number: 157SR
Recalling Firm/
Manufacturer		 Randox Laboratories Ltd.
55 Diamond Road
Crumlin (North) Ireland
Manufacturer Reason
for Recall		 A decrease in the reactivity of HSV Type 1/2 lgM in the Serology ToRCH lgM Positive Control when tested on the DiaSorin Liaison XL.
FDA Determined
Cause 2		 Process control
Action Randox issued Urgent Medical Device Correction Letter on 11/6/23 to the US Distributor Randox Laboratories-US, Ltd. , Kearneysville, West Virginia, for issuance to the user level. Letter states reason for recall, health risk and action to take: As the control material is still testing positive for HSV Type 1/2 lgM, there is no risk to health. If the control did test negative for this analyte, the affected run should be discarded, and the samples re-analysed. Action to be taken: " Discuss the contents of this notice with your Medical Director. " Complete and return the response form 12187-QA to technical.services@randox.com within five working days. " Please discard all copies of the IFU and download the latest version from www.randox.com.alth risk and action to take: (
Quantity in Commerce 1 unit
Distribution NY, WV
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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