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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 64348

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

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Event summary

Timeline bucket
February 11, 2013
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Innominata Dba Genbio

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

ANTI-BORRELIA (LYME) MICROPLATE EIA Kit, Catalog # 32507 Kit Lot Number 120960. Package Insert Supplement: Calibrator-1206 U/mL, Positive Control-228 - 532 U/mL, and Negative Control-<120 U/mL; Manufactured by Innominata dba GenBio for Bio-Rad. The kit is used as an aid in diagnosis of Lyme disease.

Z-0927-2013
Recall number
Z-0927-2013
Initiated
February 11, 2013
Classification
Class II
Status
Terminated
Recalling firm
Innominata Dba Genbio
Quantity
195

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Multiple incidents of low-reacting assay plates.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Multiple incidents of low-reacting assay plates.

Code information

Lot #120960 (121003. 121058,121002), ; Exp./Cad/Verw/bis: 2013-09; Catalog#802-3011; 25271, 25272, 25273; Label P/N 522-0040, 522-0037, 522-0011

Distribution pattern

Nationwide distribution: CA, IL, MA, MD, ME, NC, ND, NJ, NY, OR, VA and WI.