FDA Device recall 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,…
- FDA Device
- Class II
- terminated
- Published 2019-05-08
On 2019-05-08 the FDA classified a Class II recall of G-6-PDH Deficient Control (G-6-PDH CONTROL D), Catalogue Number PD2617 Product Usage: This product is intended for in vitro diagnostic use,… by Randox Laboratories, citing the target values and ranges in these lots are incorrect.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1254-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-04-03 |
| Published | 2019-05-08 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Randox Laboratories |
| Distribution | IL, NC, OH, PA, PR, WI, WV |
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
The target values and ranges in these lots are incorrect.
Identifiers
| code_info | Lot Numbers: 687PD 700PD 715PD |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1254-2019%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.