FDA Device recall Z-0905-2023
Liquid Assayed Specific Protein Control Level 3- In vitro diagnostic use, in the quality control of serum on clinical chemistry and immunoa…
- FDA Device
- Class II
- ongoing
- Published 2023-01-11
On 2023-01-11 the FDA classified a Class II recall of Liquid Assayed Specific Protein Control Level 3- In vitro diagnostic use, in the quality control of serum on clinical chemistry and immunoa… by Randox Laboratories, citing concentration of Rheumatoid Factor has decreased in Specific Protein Control Level 1-3 causing delay in reporting results due to Quality Controls running low outside range.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0905-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-11-22 |
| Published | 2023-01-11 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Randox Laboratories |
| Distribution | US |
Product
Liquid Assayed Specific Protein Control Level 3- In vitro diagnostic use, in the quality control of serum on clinical chemistry and immunoassay systems Catalog Number: PS2684
Reason
Concentration of Rheumatoid Factor has decreased in Specific Protein Control Level 1-3 causing delay in reporting results due to Quality Controls running low outside range
Identifiers
| code_info | GTIN: 05055273204919 Lot Number/Exp. Date: 586LPC 28th Jun 23; 602LPC 28th Nov 23; 628LPC 28th Dec 24; |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0905-2023%22
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