FDA Device recall Z-2207-2019
Assayed Bovine Multi-Sera Level 1, Model No. AL1027
- FDA Device
- Class III
- terminated
- Published 2019-08-14
On 2019-08-14 the FDA classified a Class III recall of Assayed Bovine Multi-Sera Level 1, Model No. AL1027 by Randox Laboratories, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2207-2019 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2019-06-10 |
| Published | 2019-08-14 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Randox Laboratories |
| Distribution | AZ, OR, WA, WV |
Product
Assayed Bovine Multi-Sera Level 1, Model No. AL1027
Reason
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.
Identifiers
| code_info | 205SL |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2207-2019%22
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