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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 86386

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

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Event summary

Timeline bucket
August 26, 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

BECKMAN COULTER ACCESS Immunoassay Systems - Access Unconjugated Estriol, REF 33570.

Z-3006-2020
Recall number
Z-3006-2020
Initiated
August 26, 2020
Classification
Class II
Status
Terminated
Recalling firm
Beckman Coulter Inc.
Quantity
21455 assay systems

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Due to alkaline phosphatase (ALP) associated interference causing falsely elevated uE3 (Unconjugated Estriol assay) results.

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

Due to alkaline phosphatase (ALP) associated interference causing falsely elevated uE3 (Unconjugated Estriol assay) results.

Code information

Catalog Number: 33570 UDI Code: (01)15099590231187 Serial/Lot Numbers: 921133 921348 921742

Distribution pattern

Worldwide distribution - U.S. Nationwide distribution including in the states of AL, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, LA, MA, MD, MI, MN, NC, NJ, NM, NY, OH, OK, OR, PA, RI, SC, TN, TX, WA, WI and Puerto Rico. The countries of Australia, Belgium, Bosnia and Herzegovina, Brazil, Canada, China, Czech Republic, Germany, Hungary, India, Ireland, Italy, Jordan, Lebanon, Malaysia, Mexico, Nepal, Pakistan, Panama, Portugal, Russia, Saudi Arabia, Serbia, Slovakia, South Africa, South Korea, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, and Vietnam.