Liquid Assayed Chemistry Control Premium Plus Level 3 — Class II medical device recall Z-2609-2023
Ongoing recall by Randox Laboratories Ltd., reported 2023-09-27, distributed in GA, OH, OR, PA, TX, VA. there has been a transcription error in the Instructions for Use (IFU) for the Liquid Assayed Chemistry Contro
| Recall number | Z-2609-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Randox Laboratories Ltd., Crumlin (North), Ireland |
| Recall initiated | 2023-08-03 |
| Classified | 2023-09-19 |
| Reported by FDA | 2023-09-27 |
| Distributed | GA, OH, OR, PA, TX, VA |
| Quantity | 66 kits |
| UPC / GTIN / UDI-DI | 05055273208986 |
| Lot numbers | 1308UE |
| Model numbers | LAE4215 |
Product
Liquid Assayed Chemistry Control Premium Plus Level 3, Catalog Number LAE4215
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2609-2023. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.