G-6-PDH Deficient Control — Class II medical device recall Z-1254-2019
Terminated recall by Randox Laboratories Ltd., reported 2019-05-08, distributed in IL, NC, OH, PA, PR, WI, WV. The target values and ranges in these lots are incorrect.
| Recall number | Z-1254-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Randox Laboratories Ltd., Crumlin (North), N/A, Ireland |
| Recall initiated | 2019-04-03 |
| Classified | 2019-05-02 |
| Reported by FDA | 2019-05-08 |
| Terminated | 2019-10-09 |
| Distributed | IL, NC, OH, PA, PR, WI, WV |
| Quantity | 14 kits |
| Lot numbers | 687PD, 700PD, 715PD |
| Model numbers | PD2617 |
Product
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
Reason for recall
The target values and ranges in these lots are incorrect.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1254-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.