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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 85533

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

Open FDA event record

Event summary

Timeline bucket
December 11, 2019
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Abaxis 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

Piccolo Xpress chemistry analyzer, Model No. 1100-1001, Software version 2.1.55 (NGA)/3.1.35(Jen II)

Z-2361-2020
Recall number
Z-2361-2020
Initiated
December 11, 2019
Classification
Class II
Status
Terminated
Recalling firm
Abaxis Inc
Quantity
15

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Incorrect reference ranges of analytes.

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

Incorrect reference ranges of analytes.

Code information

Model Number: 1100-0000; 1100-0001; Software version 2.1.55 (NGA models )/3.1.35(Jen II models) Serial Numbers:0000000P23019, 0000000P02700 0000000P22997, 0000000P24435 0000000P05910 0000000P05380 0000000P08467 0000000P06595 0000000P07622 0000000P07988 0000000P04609 0000000P24721 0000000P24495 0000000P20399 0000000P20131 0000000P02755

Distribution pattern

All U.S. Consignees, TX, PA, FL, OK, KY, CA, VA No OUS Consignees.