FDA Device recall Z-2049-2020
B-Hydroxybutyrate LiquiColor, Item code CH2440058 - Product Usage: Product is used for the quantitative determination of B-Hydroxybutyrate…
- FDA Device
- Class II
- terminated
- Published 2020-05-27
On 2020-05-27 the FDA classified a Class II recall of B-Hydroxybutyrate LiquiColor, Item code CH2440058 - Product Usage: Product is used for the quantitative determination of B-Hydroxybutyrate… by Cardinal Health, citing three products requiring refrigerated storage conditions were incorrectly stored outside of approved temperature ranges. Using these temperature abused products may result in misd….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2049-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-04-20 |
| Published | 2020-05-27 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Cardinal Health |
| Distribution | US |
Product
B-Hydroxybutyrate LiquiColor, Item code CH2440058 - Product Usage: Product is used for the quantitative determination of B-Hydroxybutyrate in human serum or plasma.
Reason
Three products requiring refrigerated storage conditions were incorrectly stored outside of approved temperature ranges. Using these temperature abused products may result in misdiagnosis of the patient.
Identifiers
| code_info | Lot 193462 |
|---|
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-2049-2020%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.