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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 66293

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

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Event summary

Timeline bucket
August 20, 2013
Product types
Device
Classifications
Class III
Statuses
Terminated
Recalling firm wording
Bio-Rad Laboratories

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

FSE Image Upgrade Kit, Catalog # 92019C This kit is used to install and/or upgrade software used with the EVOLIS Microplate System.

Z-0032-2014
Recall number
Z-0032-2014
Initiated
August 20, 2013
Classification
Class III
Status
Terminated
Recalling firm
Bio-Rad Laboratories
Quantity
23 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The FSE Image Upgrade kit (part 92019C) is recalled due to issue related to the export of data from the EVOLIS analyzer to Laboratory Information Systems (LIS) when using the MONOLISA Anti-HBs EIA Quantitative Determination in EVOLIS APF version 6.0.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The FSE Image Upgrade kit (part 92019C) is recalled due to issue related to the export of data from the EVOLIS analyzer to Laboratory Information Systems (LIS) when using the MONOLISA Anti-HBs EIA Quantitative Determination in EVOLIS APF version 6.0.

Code information

Lot 122822

Distribution pattern

US Distribution including the states of FL, IA, ME, MO, MS, NE, NY, TN, TX, and WA