FDA Device recall Z-2279-2018
Randox Liquid Assayed Specific Protein Control - Level 2 (SP Control 2), Cat. no
- FDA Device
- Class II
- terminated
- Published 2018-07-04
On 2018-07-04 the FDA classified a Class II recall of Randox Liquid Assayed Specific Protein Control - Level 2 (SP Control 2), Cat. no by Randox Laboratories, citing the recalling firm has confirmed that Free Kappa light chains in Liquid Assayed Specific Protein Controls increase over the shelf life of the product. This may lead to a delay in….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2279-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-05-22 |
| Published | 2018-07-04 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Randox Laboratories |
| Distribution | CA, GA, IN, KS, ME, PR, WV |
Product
Randox Liquid Assayed Specific Protein Control - Level 2 (SP Control 2), Cat. no. PS2683
Reason
The recalling firm has confirmed that Free Kappa light chains in Liquid Assayed Specific Protein Controls increase over the shelf life of the product. This may lead to a delay in reporting Free Kappa Light Chains results, which are used as an aid in diagnosis of monoclonal gammopathy of undetermined significance and for Multiple Myeloma through review of the ratio with free lambda chains.
Identifiers
| code_info | All lots. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2279-2018%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.