NucliSENS Lysis Buffer Extended recall
NucliSENS Lysis Buffer Extended lot for RES 76675
Why was NucliSENS Lysis Buffer Extended recalled?
Elute may become colored due to the residual presence of heme group origination from hemoglobin present in whole blood samples as well as dried spot (DBS) samples. This can potentially cause the inhibition of PCR reactions and result in an uninterpretable test result. If using an Internal Control (IC) in the extraction process the IC could potentially be inhibited as well and invalidate test results.
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?
REF 200292, Lot 17022802, Exp Date 01/28/2019 Extended lot for RES 76675
- Product
- NucliSENS Lysis Buffer Extended lot for RES 76675
- Recalling firm
- BioMerieux SA
- Quantity
- 911 units
- Distribution
- Distributed domestically to MD, CO, and OH.
- Recall date
- November 15, 2017
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)