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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 64112

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

Open FDA event record

Event summary

Timeline bucket
November 28, 2012
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Mindray DS USA, Inc. d.b.a. Mindray North America

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

BS-200 Chemistry Analyzer Designed for clinical laboratory use.

Z-0977-2013
Recall number
Z-0977-2013
Initiated
November 28, 2012
Classification
Class II
Status
Terminated
Quantity
3 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
An issue has been identified with the BS-200 where clinical chemistry results may be inaccurate.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

An issue has been identified with the BS-200 where clinical chemistry results may be inaccurate.

Code information

Part number BA20E-PA00003; Serial Numbers: WN-28103978F, WN-28103976F, and WN-28103977F.

Distribution pattern

Distributed in the states of NC and TX.