Product Wiki · Recalls · U.S. FDA — Device Enforcement

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 (1156-001, 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

U.S. FDA — Device Enforcement · United States · 2018-02-13 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1070-2018
Date of alert: 2018-02-13
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Stanbio Laboratory, LP
Product category: device
Product type: Devices

Reported risk: All patient serum samples yield a weakly positive test result.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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