Proadvantage Mono Rapid Test Cassette recall: Labeling Error
Proadvantage Mono Rapid Test Cassette, Catalog No. P080016 a simple test that utilizes an extract of bovine erythrocytes to qualitatively and…
Why was Proadvantage Mono Rapid Test Cassette recalled?
The Positive Control information referencing human plasma as the antibody material described in the product labeling and packaging is incorrect.
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?
all lots are affected
- Product
- Proadvantage Mono Rapid Test Cassette, Catalog No. P080016 a simple test that utilizes an extract of bovine erythrocytes to qualitatively and…
- Recalling firm
- Alere San Diego, Inc.
- Quantity
- N/A
- Distribution
- US
- Recall date
- August 3, 2016
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (device)