Exact FDA event identifier

Event 85959

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

Open FDA event record

Event summary

Timeline bucket: July 06, 2020
Product types: Device
Classifications: Class II
Statuses: Terminated
Recalling firm wording: Sysmex America, Inc.

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

Sysmex PS-10 Sample Preparation System Catalog number:BQ716341 - Product Usage: is a fully automated, user configurable, open system intended for use to prepare human specimens for subsequent analysis on flow cytometers.

Z-2687-2020

Recall number: Z-2687-2020
Initiated: July 06, 2020
Classification: Class II
Status: Terminated
Recalling firm: Sysmex America, Inc.
Quantity: 8 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Insufficient amount of antibody without an error message or alarm

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Insufficient amount of antibody without an error message or alarm

Code information

Serial Numbers: 1906007896 1907014703 1908002274 1908002273 1907014704 1903011967 1903011968 1903011966

Distribution pattern

US Nationwide distribution including in the states of AL, AZ, MD, WA, FL, IL.