FDA recall Z-0086-2018

Product

NucliSENS Lysis Buffer Extended lot for RES 76675

Reason for recall

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.

Distribution

Distributed domestically to MD, CO, and OH.

Key facts

Status

Terminated

Initiation date

2017-10-18

Report date

2017-11-15

Termination date

2021-08-24

Voluntary/Mandated

Voluntary: Firm initiated

Location

Marcy L'Etoile, N/A, France

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0086-2018