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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 88324

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

Open FDA event record

Event summary

Timeline bucket
July 12, 2021
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Abbott Laboratories, 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

Alinity s System REF 06P16-01. An automated immunoassay analyzer for In Vitro diagnostic use in blood donor screening, plasma and plasmapheresis screening, and organ donor centers, hospitals, and reference laboratories.

Z-2276-2021
Recall number
Z-2276-2021
Initiated
July 12, 2021
Classification
Class II
Status
Ongoing
Recalling firm
Abbott Laboratories, Inc
Quantity
260 systems

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
defect (hardware and software

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

A design defect (hardware and software) allows liquid waste pressure to build up and potentially spray users/operators.

Code information

Model Number: LN 06P16-01 Serial numbers AS1001 through AS1330

Distribution pattern

Worldwide distribution. US nationwide, Australia, Bahrain, Belgium, Brazil, China, Colombia, Croatia, Egypt, Germany, Greece, Hong Kong, Hungary, Iran, Ireland, Israel, Italy, Jordan, Kuwait, Mexico, Netherlands, Pakistan, Poland, Portugal, Saudi Arabia, Serbia, Slovenia, South Africa, Spain, Tanzania, United Arab Emirates, United Kingdom, Ukraine and Zimbabwe.

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