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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