FDA Device recall Z-1713-2017
NucliSENS Lysis Buffer, REF 200292 NucliSENS Lysis Buffer is intended to be use for the release of total nucleic acid from biological speci…
- FDA Device
- Class II
- terminated
- Published 2017-04-12
On 2017-04-12 the FDA classified a Class II recall of NucliSENS Lysis Buffer, REF 200292 NucliSENS Lysis Buffer is intended to be use for the release of total nucleic acid from biological speci… by Biomerieux, citing problem with colored eluates for whole blood extractions.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1713-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-03-07 |
| Published | 2017-04-12 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Biomerieux |
| Distribution | IL, OH, WA |
Product
NucliSENS Lysis Buffer, REF 200292 NucliSENS Lysis Buffer is intended to be use for the release of total nucleic acid from biological specimens
Reason
Problem with colored eluates for whole blood extractions
Identifiers
| code_info | Lot Number 16092902 |
|---|
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-1713-2017%22
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