Recall Z-0285-2018 ยท LCP Assay, Glycosylated Hemoglobin
Randox Laboratories Ltd.
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: Haemoglobi
| Date | Jun 7, 2017 |
| Status | Terminated |
| Reason | 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. |
| Root cause | 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 | 90 kits |
| Distribution | Puerto Rico; International: Portugal, Italy, Turkey, Slovakia, Russia, Thailand and Vietnam |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K021897 | RANDOX HAEMOGLOBIN A1C Randox Laboratories, Ltd., Nov 26, 2002 |