Z-0086-2018 Class II Terminated
FDA device recall Z-0086-2018 was initiated by BioMerieux SA on October 18, 2017 and is designated Class II. 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 inhi… The recall status is terminated (terminated August 24, 2021). Affected quantity: 911 units.
Recall Details
- Product Type
- Devices
- Report Date
- November 15, 2017
- Initiation Date
- October 18, 2017
- Termination Date
- August 24, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 911 units
Product Description
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 Pattern
Distributed domestically to MD, CO, and OH.
Code Information
REF 200292, Lot 17022802, Exp Date 01/28/2019 Extended lot for RES 76675