Chemistry QC Premium Plus — Class II medical device recall Z-1547-2020
Ongoing recall by Randox Laboratories Ltd., reported 2020-04-01, distributed nationwide. The control target and range value for Sodium using the ISE indirect method has been assigned incorrectly.
| Recall number | Z-1547-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Randox Laboratories Ltd., Crumlin (North), N/A, Ireland |
| Recall initiated | 2020-02-18 |
| Classified | 2020-03-20 |
| Reported by FDA | 2020-04-01 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, CZ, DE, FR, GB, HK, IE, IT, KR, NO, PH, SE, TH, TW, ZA |
| UPC / GTIN / UDI-DI | 05055273209006 |
| Lot numbers | 306UL |
| Model numbers | LAL4213 |
Product
Chemistry QC Premium Plus, Cat. No. LAL4213, GTIN 05055273209006 - Product Usage: This product is intended for in vitro diagnostic use, in the quality control of diagnostic assays. The device is for the control of accuracy.
Reason for recall
The control target and range value for Sodium using the ISE indirect method has been assigned incorrectly.
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-1547-2020. 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.