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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 66105

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

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Event summary

Timeline bucket
August 09, 2013
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
OPTI Medical Systems, 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

Model BP7507 OPTI LION E-Plus Cassettes 25 Cassettes with Sample Probes, OPTIMedical Cassettes are consumable used in the OPTI LION Electrolyte Analyzer intended to be used for the measurement of sodium, potassium, chloride, ionized calcium and pH in samples of whole blood, serum, and plasma.

Z-0029-2014
Recall number
Z-0029-2014
Initiated
August 09, 2013
Classification
Class II
Status
Terminated
Recalling firm
OPTI Medical Systems, Inc
Quantity
361 boxes of 25 cassettes each

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
OPTI LION E-Plus Cassettes were labeled with an incorrect barcode. The incorrect barcode could perfect the performance of one or more parameters as the product ages. Also a Customer complaint from a distributor reported that a customer was getting QC failures.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Error in labeling

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

OPTI LION E-Plus Cassettes were labeled with an incorrect barcode. The incorrect barcode could perfect the performance of one or more parameters as the product ages. Also a Customer complaint from a distributor reported that a customer was getting QC failures.

Code information

Lots 252810, 315815, 319810, 319815, 321817, 367812, 370812

Distribution pattern

Worldwide distribution: US (nationwide) including states of: CA, MA, MN, and VA; and countries of: China, Guatemala, India, Iraq, South Korea, and Untied Arab Emirates.