Exact FDA event identifier

Event 81067

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

Open FDA event record

Event summary

Timeline bucket: September 17, 2018
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¿ Magnetic Extraction Reagents

Z-0218-2019

Recall number: Z-0218-2019
Initiated: September 17, 2018
Classification: Class II
Status: Terminated
Recalling firm: BioMerieux SA
Quantity: 42 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Data loggers showed that one shipment to the United States experienced low temperatures that may impact performance of this product.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Other

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Data loggers showed that one shipment to the United States experienced low temperatures that may impact performance of this product.

Code information

Reference # 200293, Lot # 17121501, Expiration date 11/28/2018

Distribution pattern

Nationwide distribution to MD, TX, MA, GA, OH, OR, CA, and WA.