Randox HbA1c Reagent Recall: Low Calibration Risk
Randox recalls HbA1c reagents (HA3830, Batch 414553) due to potential calibration issues. This may affect blood glucose testing accuracy. Affected users should contact Randox for guidance.
Lower-risk 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.
Contact the company
What happened, in plain English
Randox is recalling HbA1c reagents (HA3830, Batch 414553) because they may not maintain calibration accuracy over time. This could lead to incorrect blood sugar test results, which is important for diabetes management. Read more at govinfonow.com/recall/73927-randox-hba1c-reagent-recall-low-calibration-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/73927-randox-hba1c-reagent-recall-low-calibration-risk · Updated September 23, 2026 · FDA enforcement record: FDA #Z-0285-2018
Cite this page
“Randox HbA1c Reagent Recall: Low Calibration Risk.” GovInfoNow, updated September 23, 2026. https://govinfonow.com/recall/73927-randox-hba1c-reagent-recall-low-calibration-risk. Based on FDA recall #Z-0285-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0285-2018%22&limit=1).
Why it’s dangerous
The reagents may not stay calibrated properly over their shelf life, leading to less accurate HbA1c measurements. This could cause incorrect blood sugar readings, which is critical for diabetes management.
Who’s affected
Users of Randox HbA1c reagents (HA3830, Batch 414553) for blood glucose testing. People with diabetes who rely on these tests are most at risk of inaccurate results.
How to tell if you have this one
Check for the product name 'HbA1c REF' with Catalog Number HA3830, Batch 414553, sold by Randox Laboratories Ltd. This reagent is used with RX Daytona or RX Imola analyzers.
- Brand
Randox- Product
Rx series HbA1c REF/Catalog Number HA3830, GTIN 05055273203561, IVD; -- RANDOX LABORATORIES LTD. , This product is- Category
Medical device
What to do — step by step
Check Reagent Batch
Verify the batch number on the reagent packaging; affected units have batch 414553.
Contact Randox
Reach out to Randox Laboratories for guidance on next steps if you have the affected batch.
Where it went and when
Where it was distributed
Distributed in Puerto Rico, and outside the U.S.
FDA distribution: “Puerto Rico; International: Portugal, Italy, Turkey, Slovakia, Russia, Thailand and Vietnam” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Puerto Rico.
Recall timeline
FDA terminated this recall 13 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-0285-2018 (June 7, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0285-2018 to see it in context.
- Plain-language summary written by qwen3:4b on September 23, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.