Class II — Stanbio Laboratory, LP
| Recalling firm | STANBIO LABORATORY |
|---|---|
| Registered facility | View this company's 2 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | All patient serum samples yield a weakly positive test result. |
| 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. |
| Quantity | 686 units |
| Distribution | Worldwide Distribution - United States nationwide , Canada, Korea, Mexico, Trinidad |
| Initiated | 2018-02-13 |
| Classified | 2018-03-15 |
| Terminated | 2018-09-27 |
| Recall number | Z-1070-2018 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Stanbio Laboratory, LP (Z-1070-2018).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/79245/
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