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U.S. Department of Health and Human Services

Class 2 Device Recall HbA1c

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  Class 2 Device Recall HbA1c see related information
Date Initiated by Firm June 07, 2017
Create Date December 22, 2017
Recall Status1 Terminated 3 on July 02, 2018
Recall Number Z-0285-2018
Recall Event ID 77611
510(K)Number K021897  
Product Classification Assay, glycosylated hemoglobin - Product Code LCP
Product Rx series HbA1c REF/Catalog Number HA3830, GTIN 05055273203561, IVD; -- RANDOX LABORATORIES LTD. , This product is suitable for use on RX series instruments which includes the RX Daytona and RX Imola analysers. Packaging Format: HbA1c R1: Antibody Reagent - 3 x 14 ml
HbA1c R2: Agglutinator Reagent - 3 x 14 ml
R3: Haemoglobin Denaturant Reagent - 3 x 50 ml
Hb R1: Total Haemoglobin Reagent - 3 x 28 ml


For Professional Use in the quantitative in vitro determination of Haemoglobin A1c concentration in whole blood.
Code Information Lot/Batch 414553, expiry 28th Jan 2019
Recalling Firm/
Manufacturer		 Randox Laboratories Ltd.
55 Diamond Road
Crumlin (North) Ireland
Manufacturer Reason
for Recall		 Randox confirmed low calibration absorbance with HbA1c, Catalog Number HA3830, Batch 414553. The reagent may not continue to meet its specific performance characteristics throughout the shelf life of the product.
FDA Determined
Cause 2		 Under Investigation by firm
Action Randox Laboratories sent an Urgent Field Safety Notice dated June 6, 2017, sent to all global consignees on June 7, 2017, via e-mail. This includes the sole US consignee. Customers are advised to dispose of any existing stock and to contact technical support with respect to reimbursement for loss of material. The company will follow up every 2 weeks over a six week period with the consignees. For further questions, please call (304) 728-2890.
Quantity in Commerce 90 kits
Distribution Puerto Rico; International: Portugal, Italy, Turkey, Slovakia, Russia, Thailand and Vietnam
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 = LCP and Original Applicant = RANDOX LABORATORIES, LTD.
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