Lower riskMedical device recall · FDA · Published February 13, 2019
Randox BG50: Blood Gas Control pH Error Risk - Recall
Randox recalls BG5002 Blood Gas Control Level 2 due to pH range error in in-vitro diagnostics. This affects blood gas analysis quality control. No remedy specified in official notice.
“Randox BG50: Blood Gas Control pH Error Risk - Recall.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/69008-randox-bg50-blood-gas-control-ph-error-risk-recall. Based on FDA recall #Z-1057-2019 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1057-2019%22&limit=1).
The FDA announced on Feb. 13, 2019, that Randox Laboratories Ltd. voluntarily recalled its Randox Blood Gas Control Level 2 (Model BG5002) due to an error in the assigned control range for pH. The agency classified the recall as Class II.
How to tell if you have it
Brand: Randox
Product: Randox Blood Gas Control Level 2 - Model BG5002
UPC: 05055273227116
Lot Code: 184BG
The hazard
The recall addresses an error in the assignment of the control range pH in Blood Gas Control, according to the FDA. The product is intended for in vitro diagnostic use in the quality control of blood gas analysis.
Context
GovInfoNow's records show Randox Laboratories Ltd. has 49 other recalls on record since June 7, 2017. Recent brand recalls include a Cystatin C Reagent recall on June 7, 2024, for missing FDA 510(k) clearance, an Evidence MultiSTAT Software v3.7 recall on April 5, 2024, involving light leak risks, and a Clinical Chemistry Calibration Serum recall on March 5, 2024, regarding inorganic phosphate bias. Other recent recalls of similar products include Siemens Epoc Blood Test Cards (April 2, 2026) and Abbott i-STAT EG6+ and G3+ Cartridges (April 1, 2026).
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
Product
Randox Blood Gas Control Level 2 -Model BG5002. In-vitro Diagnostic Quality control of Blood Gas analysis This product
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.
Where it went and when
Where it was distributed
Distributed in West Virginia.
Listed by the agency
Not listed
FDA distribution: “US Distribution to state of: WV” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: West Virginia.
Recall timeline
FDA terminated this recall 14 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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.