Exact FDA event identifier

Event 87960

2 recalled-product records grouped only because every row carries this exact official event ID.

Event summary

Timeline bucket: May 07, 2021
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

2 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 2

Access SARS CoV-2 lgG II Reagent, REF: C69057, IVD CE UDI: (01)15099590742744

Z-1905-2021

Recall number: Z-1905-2021
Initiated: May 07, 2021
Classification: Class II
Status: Terminated
Recalling firm: Beckman Coulter Inc.
Quantity: 13,337 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

SARS-CoV-2 lgG II numerical results may potentially be multiplied by a factor of 1000 on systems running with assay protocol file (APF) and access assay file (AAF) versions resulting in falsely elevated numerical values.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software Design Change

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

SARS-CoV-2 lgG II numerical results may potentially be multiplied by a factor of 1000 on systems running with assay protocol file (APF) and access assay file (AAF) versions resulting in falsely elevated numerical values.

Code information

All Lots

Distribution pattern

US: Alabama, Alaska, Arizona, Arkansas, California, Florida, Georgia, Illinois, Iowa, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Mississippi, Missouri, New Hampshire, New Jersey, New York, North Dakota, Ohio, Oklahoma, Pennsylvania, Puerto Rico, Tennessee, Texas, Virginia, West Virginia, Wisconsin, Wyoming, OUS: Andorra, Austria, Croatia, Czech Republic, France, Germany, Gibraltar, Greece, Hong Kong, Hungary, Israel, Italy, Japan, Jordan, Poland, Portugal, San Marino, Slovakia, Slovenia, Spain, United Arab Emirates

device · product 2 of 2

Access SARS-CoV-2 lgG II Calibrator, REF C69058, IVD, CE UDI: (01)15099590742751

Z-1906-2021

Recall number: Z-1906-2021
Initiated: May 07, 2021
Classification: Class II
Status: Terminated
Recalling firm: Beckman Coulter Inc.
Quantity: 3,843 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

SARS-CoV-2 lgG II numerical results may potentially be multiplied by a factor of 1000 on systems running with assay protocol file (APF) and access assay file (AAF) versions resulting in falsely elevated numerical values.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software Design Change

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Code information

All Lots