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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 87146

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

Open FDA event record

Event summary

Timeline bucket
December 30, 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

ACCESS SARS-CoV-2 IgG QC SARS-CoV-2 IgG REF C58964 - Product Usage: use on the Access Family of Immunoassay Systems only.

Z-0875-2021
Recall number
Z-0875-2021
Initiated
December 30, 2020
Classification
Class II
Status
Terminated
Recalling firm
Beckman Coulter Inc.
Quantity
276 units

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
label error
Manufacturing or process control reason.manufacturing_process_control · v1.0.0
Quality Control (QC) card has a label error for the standard deviation

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling mix-ups

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The Quality Control (QC) card has a label error for the standard deviation (SD) values for one out of the two levels of QC.

Code information

Catalog Number: C58964 UDI Code: 15099590738662 Lot Number: 922407

Distribution pattern

Worldwide distribution - U.S. Nationwide distribution including in the states of AL, AZ, CA, FL, GA, IA, ID, IL, IN, KS,KY, LA, MD, MI, MN, MO, NC, ND, NY, OH, OK, OR, PA, Puerto Rico, SD, TX, WA, and WV. The countries of Andorra, Belgium, Brazil, Bulgaria, Canada*, Croatia, France, Germany, Hong Kong, Italy, Jordan, Mexico, Paraguay, Poland, Portugal, Romania, Spain, and United Kingdom.