Assayed Bovine Multi-Sera Level 1 — Class III medical device recall Z-2207-2019
Terminated recall by Randox Laboratories, Limited, reported 2019-08-14, distributed in AZ, OR, WA, WV. The firm is re-assigning the Mean of all Instruments target and range for Bile Acids (5th Generation Colorimet
| Recall number | Z-2207-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Randox Laboratories, Limited, Crumlin, N/A, United Kingdom |
| Recall initiated | 2019-06-10 |
| Classified | 2019-08-07 |
| Reported by FDA | 2019-08-14 |
| Terminated | 2020-06-16 |
| Distributed | AZ, OR, WA, WV |
| Countries outside the US | AU, CA, CH, DE, FR, GB, IE, KE, KR, LT, NG, NZ, OM, RU, SE, SG, TR, ZA |
| Quantity | 4 kits |
| Model numbers | AL1027 |
Product
Assayed Bovine Multi-Sera Level 1, Model No. AL1027
Reason for recall
The firm is re-assigning the Mean of all Instruments target and range for Bile Acids (5th Generation Colorimetric) in the Assayed Bovine Multi-Sera Level 1 Control Lot 205SL.
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-2207-2019. 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.