Exact FDA event identifier

Event 68749

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

Open FDA event record

Event summary

Timeline bucket: October 14, 2013
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

VIDAS TPSA, in vitro diagnostic, for use as an automated quantitative measurement of prostate specific antigen levels in human serum or plasma.

Z-2152-2014

Recall number: Z-2152-2014
Initiated: October 14, 2013
Classification: Class II
Status: Terminated
Recalling firm: BioMerieux SA
Quantity: 1902

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Product is not approved or authorized for distribution in the US.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product is not approved or authorized for distribution in the US.

Code information

Lot 1001904130

Distribution pattern

FL, LA, MI, MS, NV, OH, OK, TN, TX