RecallRadar

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…

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

AgencyFDA Device
Recall numberZ-1713-2017
ClassificationClass II
Statusterminated
Initiated2017-03-07
Published2017-04-12
Last updated2026-09-13 11:54 UTC
CompanyBiomerieux
DistributionIL, 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_infoLot 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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