BioMerieux SA: Medical Device Recall in 2017 - (Recall #: Z-0086-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2017.

Data Source: FDA.

Product Description:

NucliSENS Lysis Buffer Extended lot for RES 76675

Product Classification:

Class II

Date Initiated: October 18, 2017

Date Posted: November 15, 2017

Recall Number: Z-0086-2018

Event ID: 78387

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.

Status: Terminated

Product Quantity: 911 units

Code Information:

REF 200292, Lot 17022802, Exp Date 01/28/2019 Extended lot for RES 76675

Distribution Pattern:

Distributed domestically to MD, CO, and OH.

Voluntary or Mandated:

Voluntary: Firm initiated