RaPET¿ RF Latex Reagent used as a component in the recall
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#…
Why was RaPET¿ RF Latex Reagent used as a component in the recalled?
All patient serum samples yield a weakly positive test result.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot 21675
- 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#…
- Recalling firm
- Stanbio Laboratory, LP
- Quantity
- 686 units
- Distribution
- Worldwide Distribution - United States nationwide , Canada, Korea, Mexico, Trinidad
- Recall date
- March 21, 2018
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)