FDA Device recall Z-1070-2018
RaPET¿ RF Latex Reagent used as a component in the following kits: RaPET RF (1155-100, Control# 173201 expiry 2019-04-30) RF Latex (1156-00…
- FDA Device
- Class II
- terminated
- Published 2018-03-21
On 2018-03-21 the FDA classified a Class II recall of RaPET¿ RF Latex Reagent used as a component in the following kits: RaPET RF (1155-100, Control# 173201 expiry 2019-04-30) RF Latex (1156-00… by Stanbio Laboratory, citing all patient serum samples yield a weakly positive test result.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1070-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-02-13 |
| Published | 2018-03-21 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Stanbio Laboratory |
| Distribution | US |
Product
RaPET¿ RF Latex Reagent used as a component in the following kits: RaPET RF (1155-100, Control# 173201 expiry 2019-04-30) RF Latex (1156-001, Control# 172224 expiry 2019-12-31) RF Latex (1155L-100B, Control # 172701 expiry 2019-09-30 and Control # 173262 expiry 2019-12-31) Product Usage: RaPET¿ RF is intended for the qualitative and semiquantitative detection of rhematoid factor in human serum. The latex slide test is intended to be used as an aid in the diagnosis of rheumatoid arthritis.
Reason
All patient serum samples yield a weakly positive test result.
Identifiers
| code_info | Lot 21675 |
|---|
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-1070-2018%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.