FDA Device recall Z-2752-2020
Randox Lipase Assay: Lipase Colorimetric R1 Buffer - Product Usage: A Lipase test system is a device intended for the quantitative in vitro…
- FDA Device
- Class II
- terminated
- Published 2020-08-12
On 2020-08-12 the FDA classified a Class II recall of Randox Lipase Assay: Lipase Colorimetric R1 Buffer - Product Usage: A Lipase test system is a device intended for the quantitative in vitro… by Randox Laboratories, citing randox have confirmed imprecision of quality control and patient samples when using specific Randox Lipase buffer batches.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2752-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-06-26 |
| Published | 2020-08-12 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Randox Laboratories |
| Distribution | US |
Product
Randox Lipase Assay: Lipase Colorimetric R1 Buffer - Product Usage: A Lipase test system is a device intended for the quantitative in vitro determination of Lipase in human serum and plasma.
Reason
Randox have confirmed imprecision of quality control and patient samples when using specific Randox Lipase buffer batches.
Identifiers
| code_info | Catalogue Numbers: LI011/004/UL, LI011/000/UL Lot #: 1048LI, 1050LI |
|---|
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-2752-2020%22
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