InSite HER-2 Detection Kit recall
InSite HER-2 Detection Kit, an immunohistochemistry assay for in vitro diagnostic use.
Why was InSite HER-2 Detection Kit recalled?
Product was distributed without 510(k) approval.
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?
Catalog number RD471-60K: Lot numbers: RD4710111, Exp Jan 2012; RD4710411, Exp. Apr 2012; RD4711013, Exp Oct 2014.
- Product
- InSite HER-2 Detection Kit, an immunohistochemistry assay for in vitro diagnostic use.
- Recalling firm
- Biogenex Laboratories, Inc.
- Quantity
- 4 kits
- Distribution
- Brazil and Ecuador. No US distribution
- Recall date
- July 30, 2014
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)