Randox G-6-PDH Control Kit: Incorrect Target Values Risk
Randox recalls G-6-PDH Normal Control kits with incorrect target values for glucose-6-phosphate dehydrogenase testing. Affected lots may cause inaccurate blood test results.
Lower-risk recall
The target values and ranges in these lots are incorrect.
Contact the company
What happened, in plain English
Rando: G-6-PDH Normal Control kits with incorrect target values are being recalled. Using these kits could lead to inaccurate blood test results, which might affect diagnosis and treatment decisions. Read more at govinfonow.com/recall/68495-randox-g-6-pdh-control-kit-incorrect-target-values-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/68495-randox-g-6-pdh-control-kit-incorrect-target-values-risk · Updated August 20, 2026 · FDA enforcement record: FDA #Z-1255-2019
Cite this page
“Randox G-6-PDH Control Kit: Incorrect Target Values Risk.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/68495-randox-g-6-pdh-control-kit-incorrect-target-values-risk. Based on FDA recall #Z-1255-2019 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1255-2019%22&limit=1).
Why it’s dangerous
The target values in these kits are incorrect, which means blood test results could be inaccurate. This might lead to wrong diagnoses or treatment decisions if the kits are used for glucose-6-phosphate dehydrogenase testing.
Who’s affected
People who use these kits for blood glucose testing may have inaccurate results. Laboratory staff and healthcare providers using the kits for quality control are most at risk.
How to tell if you have this one
Check the lot numbers on the kit: 676PD, 701PD, or 716PD. These kits are used for in vitro diagnostic testing of blood glucose.
- Brand
Randox- Category
Medical device
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Terminated- Distribution
The products were distributed to the following US states: IL, OH, NC, PA, WI, WV and Puerto Rico.
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| Z-1254-2019 | G-6-PDH Deficient Control (G-6-PDH CONTROL D), Catalogue Number PD2617 Product Usage: This product is intended for in vitro diagnostic use, in the quality control of Glucose-6-Phosphate Dehydrogenase in erythrocytes; Lot Numbers: 687PD 700PD 715PD | 14 kits |
| Z-1255-2019 | G-6-PDH Normal Control (G-6-PDH CONTROL N), Catalogue Number PD2618 Product Usage: This product is intended for in vitro diagnostic use, in the quality control of Glucose-6-Phosphate Dehydrogenase in erythrocytes; Lot Numbers: 676PD 701PD 716PD | 10 kits |
What to do — step by step
Check Kit Lot Number
Look for lot numbers 676PD, 701PD, or 716PD on the G-6-PDH Normal Control kit.
Where it went and when
Where it was distributed
Distributed in 6 states and Puerto Rico.
FDA distribution: “The products were distributed to the following US states: IL, OH, NC, PA, WI, WV and Puerto Rico.” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Illinois, North Carolina, Ohio, Pennsylvania, Puerto Rico, West Virginia, Wisconsin.
Recall timeline
FDA terminated this recall 6 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-1255-2019 (April 3, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1255-2019 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.