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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 71406

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

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Event summary

Timeline bucket
May 13, 2015
Product types
Device
Classifications
Class III
Statuses
Terminated
Recalling firm wording
Bio-Rad Laboratories, 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

The spare component Anti-HBs Cutoff Calibrator, 10 mLU/mL, Catalog number 26154. The spare component is sold separately from the MONOLISA Anti-HBs EIA Kit contains an expiration date of 2016-04-30 in error.

Z-1840-2015
Recall number
Z-1840-2015
Initiated
May 13, 2015
Classification
Class III
Status
Terminated
Quantity
20 vials

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
label in error

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Incorrect or no expiration date

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The spare component Anti-HBs Cutoff Calibrator, Catalog number 26154, is recalled because the expiration date of 2016-04-30 printed on label in error.

Code information

lot no. 11130382, expiration date 2016-04-30

Distribution pattern

US Distribution to the states of : AZ, CA, ID, MO, and NH.