Randox BG50: Blood Gas Control pH Error Risk - Recall

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Recalling firmRandox Laboratories Ltd.55 Diamond Road, N/A · Crumlin (North), N/A N/A

No email on file — write to the address above instead.

✎ GovInfoNow plain-language explainer

What happened, in plain English

Randox is recalling its BG5002 Blood Gas Control Level 2 product because of an error in the pH control range for blood gas analysis. This could lead to inaccurate test results if used in medical diagnostics.

Why it’s dangerous

The product contains an incorrect pH control range setting, which could cause inaccurate blood gas analysis results. This error might lead to improper medical decisions if used in diagnostic testing without correction.

Who’s affected

Healthcare facilities using this blood gas control product for in-vitro diagnostics are affected. Medical labs that rely on this specific model for quality control testing are most at risk.

How to tell if you have this one

Check for the model number BG5002 on the product label. The lot code 184BG and GTIN 05055273227116 are specific identifiers for this recall.

Brand
Randox
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Product Label
Look for the model number BG5002 and lot code 184BG on the product label.

✎ GovInfoNow

Questions people ask

Is this product safe to use?

The official recall notice states there is an error in the pH control range, but does not specify if it's safe to use without correction.

What should I do if I have this product?

The recall notice does not specify any remedy or action steps for affected products.

How can I confirm if my product is recalled?

Check for the model number BG5002 and lot code 184BG on the product label.

Take action

Contact Randox

We’ve drafted a message you can send Randox to request your refund or repair — edit it as you like.

✉️ Open in email

Subject: Recall Z-1057-2019 — Randox Randox

Hello,

I own a Randox that is covered by recall Z-1057-2019 from Randox.

I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this?

Thank you.

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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-1057-2019 (February 13, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1057-2019 to see it in context.
Plain-language summary written by qwen3:4b on August 20, 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.

Randox Laboratories Ltd. recalls Randox Blood Gas Control Level 2 -Model BG5002. In-vitro Diagnostic Quality control of Blood Gas analysis This product

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