Reported Mar 21, 2018 · Terminated

RaPET¿ RF Latex Reagent used as a component in the following kits: RaPET RF (1155-100, Control# 173201 expiry…

Stanbio Laboratory, LP

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Stanbio Laboratory, LP · 1261 N Main St · Boerne, TX · 78006-3014

Is this the product you have?

  • RaPET¿ RF Latex Reagent used
  • as a component in the following kitsRaPET 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 UsageRaPET¿ 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
Lot codes and dates
  • Lot 21675
Amount recalled
686 units

Where it was sold

  • Nationwide

Why it was recalled

All patient serum samples yield a weakly positive test result.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Sep 27, 2018 · Data as of Sep 19, 5:28 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.