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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 62606

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

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Event summary

Timeline bucket
July 03, 2012
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.

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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

BP7561 OPTI CCA-TS B-Lac Cassette (25 per box) Cassettes are consumables used in the OPTI CCA-TS Analyzer intended to be used for in vitro measurements of pH, PCOX2 PO2, lactate (lactic acid), total hemoglobin (tHb), and oxygen saturation (SO2), in heparinized whole blood samples (either arterial or venous) on the OPTI CCA-TS system, in either a clinical setting or point of care locations. Cassettes contain one-time use sensors that are used with the OPTI CCA-TS analyzer to perform in-vitro measurements of blood gases and metabolites. OPTI CCA-TS B-Lac Cassettes are supplied in boxes of 25 and may only used with the OPTI CCA-TS Analyzer.

Z-2440-2012
Recall number
Z-2440-2012
Initiated
July 03, 2012
Classification
Class II
Status
Terminated
Recalling firm
OPTI Medical Systems, Inc
Quantity
895 boxes (25 cassettes per box)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The values reported for PCO2 by BP7561 B-Lac cassettes are biased at high concentrations when used at altitudes above 2800 feet (853 meters).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process design

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Inspect official wording and provenance

Reason for recall

The values reported for PCO2 by BP7561 B-Lac cassettes are biased at high concentrations when used at altitudes above 2800 feet (853 meters).

Code information

Lot numbers: 110650, 114650, 114651, 114652, 114653, 116650, 116652, 117650, 118651, 121650, 121651, 122652, 122652, 122653, 122654, 122655, 122656, 122657, 123654, 123655, 124650, 133650, 134651, 136650, 146650, 149650, 202650, 208650, 208651, 209560, 209651, 211650, 212651, 213650, 214650, 215650, 215651, 221650, 222650 and 224650.

Distribution pattern

Worldwide Distribution -- US (nationwide) including the states of AZ, ID, TX and UT., and the countries of Argentina, Bolivia, China, Ecuador, France, Germany Greece, India, Indonesia, Iran, Ireland, Japan, Kuwait, Lithuania, Luxembourg, Malaysia, Mexico, Morocco, Nigeria, Poland, Romania, Russia, Saudi Arabia, Singapore, South Africa, Sudan Switzerland, Turkey, United kingdom, Venezuela, and Viet Nam.