Z-2440-2012Class II

BP7561 OPTI CCA-TS B-Lac Cassette (25 per box) Cassettes are consumables used in the OPTI CCA-TS Analyzer...

Name: Z-2440-2012 BP7561 OPTI CCA-TS B-Lac Cassette (25 per box) Cassettes are consumables used in the OPTI CCA-TS Analyzer...
Creator: OPTI Medical Systems, Inc
Published: 2012-07-03
License: https://open.fda.gov/license/

Opti Medical Systems Inc / initiated 2012-07-03 / Terminated / root cause: manufacturing process

FDA source

OPTI Medical Systems, Inc began a recall of 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... on 2012-07-03. FDA classified it as Class II and gives the reason as "The values reported for PCO2 by BP7561 B-Lac cassettes are biased at high concentrations when used at altitudes above 2800 feet (853 meters)". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2440-2012
Classification: Class II
Status: Terminated
Initiated: 2012-07-03
Posted: 2012-09-21
Terminated: 2013-04-11
Recalling firm: Opti Medical Systems Inc
Product: 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.
Product code: CHL Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
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).
Root cause tag: manufacturing process
FDA root cause: Process design
Action: OPTI Medical sent a Urgent Field Correction Notice dated July 3, 2012, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were instructed to apply correlation factors to correct the PCO2 measurement reported by the device. They were instructed to determine the elevation (altitude above sea level) for their location and to use the tables provided in the recall notification to determine the correct correlation factor. A website was provided if the consignee did not know their elevation. Steps were provided to enter the correlation factor into their OPTI CCA TS analyzer. Please contact OPTI Medical Technical Support at 1-770-510-4444 or 1-800-490-6784.
Quantity in commerce: 895 boxes (25 cassettes per box)
Distribution: 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.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2440-2012
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2440-2012	Class II	Terminated	Voluntary: Firm initiated	2012-10-03	2012-09-21

Product code CHL

K093280Class IIOpti Cca-Ts, B-Lac Cassette Model Bp7561Opti Medical Systems, Inc. / cleared 2011-01-07

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)