Genesys 1 Reagent recall
Genesys 1 Reagent, REF 01-03-0020 intended to be used with automated high performance liquid chromatography (HPLC) systems employing ion exchange…
Why was Genesys 1 Reagent recalled?
lack of 510K
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 serial numbers
- Product
- Genesys 1 Reagent, REF 01-03-0020 intended to be used with automated high performance liquid chromatography (HPLC) systems employing ion exchange…
- Recalling firm
- Clark Laboratories, Inc. (dba,Trinity Biotech USA)
- Quantity
- 252 units
- Distribution
- IL, WV, NJ, AZ, MD, UT
- Recall date
- December 26, 2018
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)