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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 89655

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

Open FDA event record

Event summary

Timeline bucket
February 16, 2022
Product types
Device
Classifications
Class III
Statuses
Ongoing
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

Beckman Coulter IRISpec CA/CB/CC control, Catalog #800-7211, containing 3 x 100 mL bottles each of CA Control, CB Control, and CC Control.

Z-0984-2022
Recall number
Z-0984-2022
Initiated
February 16, 2022
Classification
Class III
Status
Ongoing
Recalling firm
Beckman Coulter, Inc.
Quantity
12,306 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
IRISpec CA failures for glucose.

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

IRISpec CA failures for glucose.

Code information

Lot #583-21 and higher, UDI 10837461002611.

Distribution pattern

Worldwide distribution - US Nationwide, including Puerto Rico and the countries of Brazil, Canada, Curacao, Guatemala, Mexico, Philippines, Singapore, and Taiwan.