Calibration Serum Level 3 — Class II medical device recall Z-1563-2021
Terminated recall by Randox Laboratories Ltd., reported 2021-05-19, distributed in CA, CT, DC, IL, IN, MA, MD, MN…. Randox can confirm a positive bias for Total Bilirubin and Direct Bilirubin of up to +15% across the assay ran
| Recall number | Z-1563-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Randox Laboratories Ltd., Crumlin (North), Ireland |
| Recall initiated | 2021-03-29 |
| Classified | 2021-05-12 |
| Reported by FDA | 2021-05-19 |
| Terminated | 2021-11-22 |
| Distributed | CA, CT, DC, IL, IN, MA, MD, MN, MS, NE, NJ, NY, OR, PR, TX, VA |
| Countries outside the US | AR, AU, BD, BO, CA, CH, CO, CY, DE, DK, EE, EG, ES, FR, GB, GR, HK, IE, IQ, IT, JO, KE, KR, LK, LT, LU, MX, NL, NP, NZ, PK, PL, PT, QA, RO, RU, SA, SE, SI, SK, TH, TR, UA, VN, ZA |
| Quantity | 98 kits |
| Reason classes | potency |
| UPC / GTIN / UDI-DI | 05055273200966 |
| Lot numbers | 1162UE |
| Model numbers | CAL2351 |
Product
Calibration Serum Level 3 (CAL 3) - multi-analyte mixture calibrator. Catalogue Number: CAL2351
Reason for recall
Randox can confirm a positive bias for Total Bilirubin and Direct Bilirubin of up to +15% across the assay ranges when using calibrator CAL2351, lot 1162UE. The positive bias has been attributed to bilirubin instability in the calibrator and is evident in both Quality Control (QC) and Patient samples.
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-1563-2021. 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.