FDA Device recall Z-0086-2018
NucliSENS Lysis Buffer Extended lot for RES 76675
- FDA Device
- Class II
- terminated
- Published 2017-11-15
On 2017-11-15 the FDA classified a Class II recall of NucliSENS Lysis Buffer Extended lot for RES 76675 by Biomerieux, citing 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 potent….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0086-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-10-18 |
| Published | 2017-11-15 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Biomerieux |
| Distribution | CO, MD, OH |
Product
NucliSENS Lysis Buffer Extended lot for RES 76675
Reason
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.
Identifiers
| code_info | REF 200292, Lot 17022802, Exp Date 01/28/2019 Extended lot for RES 76675 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0086-2018%22
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