Reported Jan 3, 2018 · Terminated
Rx series HbA1c REF/Catalog Number HA3830, GTIN 05055273203561, IVD; -- RANDOX LABORATORIES LTD. , This product is…
Randox Laboratories Ltd.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Randox Laboratories Ltd. · 55 Diamond Road · Crumlin (North), N/A · N/A
Is this the product you have?
- 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 FormatHbA1c
- R1Antibody
- Reagent - 3 x 14 ml HbA1c R2Agglutinator
- Reagent - 3 x 14 ml R3Haemoglobin
- Denaturant Reagent - 3 x 50 ml Hb R1Total Haemoglobin Reagent - 3 x 28 ml For Professional Use in the quantitative in vitro determination of Haemoglobin A1c concentration in whole blood
- Lot codes and dates
Lot/Batch 414553expiry 28th Jan 2019
- Amount recalled
- 90 kits
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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