RaPET¿ RF Latex Reagent used as a component in the following kits:… — Class II medical device recall Z-1070-2018
Terminated recall by Stanbio Laboratory, LP, reported 2018-03-21, distributed nationwide. All patient serum samples yield a weakly positive test result.
| Recall number | Z-1070-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Stanbio Laboratory, LP, Boerne, TX, United States |
| Recall initiated | 2018-02-13 |
| Classified | 2018-03-15 |
| Reported by FDA | 2018-03-21 |
| Terminated | 2018-09-27 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA, KR, MX, TT |
| Quantity | 686 units |
| Lot numbers | 21675 |
| Expiration dates | 2019-04-30, 2019-09-30, 2019-12-31 |
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 for recall
All patient serum samples yield a weakly positive test result.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1070-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.