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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 85047

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

Open FDA event record

Event summary

Timeline bucket
February 17, 2020
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Beckman Coulter, 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

iChemVELOCITY Strips, Catalog 800-7212

Z-1535-2020
Recall number
Z-1535-2020
Initiated
February 17, 2020
Classification
Class II
Status
Terminated
Recalling firm
Beckman Coulter, Inc.
Quantity
10822 vials

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The Leukocyte and Compensation pads were switched on some vials of lot number 7212269M of the iChem VELOCITY Strips.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The Leukocyte and Compensation pads were switched on some vials of lot number 7212269M of the iChem VELOCITY Strips.

Code information

Catalog 800-7212, UDI 10837461002628; Lot 7212269M

Distribution pattern

Distribution in US including Puerto Rico, Canada, and Taiwan