Exact FDA event identifier

Event 75511

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

Open FDA event record

Event summary

Timeline bucket: August 16, 2016
Product types: Device
Classifications: Class II
Statuses: Terminated
Recalling firm wording: Lsi Medience Corporation

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

Pathfast D-Dimer, Reference number: PF1051-KUS

Z-0646-2017

Recall number: Z-0646-2017
Initiated: August 16, 2016
Classification: Class II
Status: Terminated
Recalling firm: Lsi Medience Corporation
Quantity: 42 boxes (each containing 60 test cartridges/one kit contains 10 reagent cartridge trays and one tray has 6 cartridges).

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Two complaints were received about decrease in sensitivity (control value and/or calibration value) of the product.

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

Two complaints were received about decrease in sensitivity (control value and/or calibration value) of the product.

Code information

Lot T528

Distribution pattern

US Distribution to the states of : AL, FL, ID and MA.