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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 78387

1 recalled-product record grouped only because every row carries this exact official event ID.

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Event summary

Timeline bucket
October 18, 2017
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
BioMerieux SA

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

NucliSENS Lysis Buffer Extended lot for RES 76675

Z-0086-2018
Recall number
Z-0086-2018
Initiated
October 18, 2017
Classification
Class II
Status
Terminated
Recalling firm
BioMerieux SA
Quantity
911 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

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.

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.