FDA Device recall Z-2609-2023
Liquid Assayed Chemistry Control Premium Plus Level 3, Catalog Number LAE4215
- FDA Device
- Class II
- ongoing
- Published 2023-09-27
On 2023-09-27 the FDA classified a Class II recall of Liquid Assayed Chemistry Control Premium Plus Level 3, Catalog Number LAE4215 by Randox Laboratories, citing there has been a transcription error in the Instructions for Use (IFU) for the Liquid Assayed Chemistry Control Premium Plus Level 3. For Caeruloplasmin, the one and two standard….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2609-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-08-03 |
| Published | 2023-09-27 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Randox Laboratories |
| Distribution | GA, OH, OR, PA, TX, VA |
Product
Liquid Assayed Chemistry Control Premium Plus Level 3, Catalog Number LAE4215
Reason
there has been a transcription error in the Instructions for Use (IFU) for the Liquid Assayed Chemistry Control Premium Plus Level 3. For Caeruloplasmin, the one and two standard deviation values printed on the sheet are incorrect, which may lead to misreporting patient results. Target and range values are correct, and risk is mitigated; most clinical labs will use the target and range values in clinical practice.
Identifiers
| code_info | UDI-DI: 05055273208986; Lot Number: 1308UE |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2609-2023%22
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