FDA Device recall Z-1057-2019
Randox Blood Gas Control Level 2 -Model BG5002
- FDA Device
- Class II
- terminated
- Published 2019-04-03
On 2019-04-03 the FDA classified a Class II recall of Randox Blood Gas Control Level 2 -Model BG5002 by Randox Laboratories, citing an error in the assignment of the control range pH in Blood Gas Control.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1057-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-02-13 |
| Published | 2019-04-03 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Randox Laboratories |
| Distribution | WV |
Product
Randox Blood Gas Control Level 2 -Model BG5002. In-vitro Diagnostic Quality control of Blood Gas analysis This product is intended for in vitro diagnostic use, in the quality control of Blood Gas analysis. Target values and ranges are supplied for the following analytes: Calcium, Chloride, Glucose, Lactate, PCO2, pH, pO2, Potassium, Sodium and Total CO2.
Reason
An error in the assignment of the control range pH in Blood Gas Control
Identifiers
| code_info | Lot Code: 184BG GTIN: 05055273227116 |
|---|
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-1057-2019%22
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