Liquid Clinical Chemistry Control — Class III medical device recall Z-1100-2020
Terminated recall by Randox Laboratories Ltd., reported 2020-02-12, distributed in DE, NY. A transcription error has occurred for the Randox Lipase colorimetric value in Liquid Clinical Chemistry Contr
| Recall number | Z-1100-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Randox Laboratories Ltd., Crumlin (North), N/A, Ireland |
| Recall initiated | 2019-12-13 |
| Classified | 2020-02-06 |
| Reported by FDA | 2020-02-12 |
| Terminated | 2020-10-02 |
| Distributed | DE, NY |
| Countries outside the US | AU, CH, CR, EC, ES, FR, HK, LT, NZ, PL, TR |
| Quantity | 2 |
| UPC / GTIN / UDI-DI | 05055273208993 |
| Lot numbers | 1021UE |
| Model numbers | LAE4217 |
| Expiration dates | 2020-06-28 |
Product
Liquid Clinical Chemistry Control, Catalogue Number: LAE4217, Size: 12 x 5 ml
Reason for recall
A transcription error has occurred for the Randox Lipase colorimetric value in Liquid Clinical Chemistry Control lot 1021 UE. The target and range are listed as 50 U/L (40 - 60) and should be 72U/L (58 - 86).
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-1100-2020. 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.