Z-2558-2011

OPTI LION E-Plus Cassette, Model BP7507, Opti Medical (25 Cassettes with Samples Probes per box). Cassettes...

Name: Z-2558-2011 OPTI LION E-Plus Cassette, Model BP7507, Opti Medical (25 Cassettes with Samples Probes per box). Cassettes...
Creator: OPTI Medical Systems, Inc
Published: 2011-03-15
License: https://open.fda.gov/license/

Opti Medical Systems Inc / initiated 2011-03-15 / Terminated / root cause: manufacturing process

FDA source

OPTI Medical Systems, Inc began a recall of OPTI LION E-Plus Cassette, Model BP7507, Opti Medical (25 Cassettes with Samples Probes per box). Cassettes are consumables used in the OPTI LION Electrolyte... on 2011-03-15. The reason FDA records is "The values reported by the chloride sensors may report erroneous values below specification on aqueous controls and potentially with patient samples of whole blood and serum/plasma". 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-2558-2011
Status: Terminated
Initiated: 2011-03-15
Posted: 2011-06-14
Terminated: 2011-08-08
Recalling firm: Opti Medical Systems Inc
Product: OPTI LION E-Plus Cassette, Model BP7507, Opti Medical (25 Cassettes with Samples Probes per box). Cassettes are consumables 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. . Cassettes contain one-time use sensors that are used with the OPTI-LION analyzer to perform in-vitro measurements of electrolytes. OPTI LION E-Plus Cassettes are supplied in boxes of 25 and may only be used with the OPTI LION Electrolyte Analyzer.
Product code: CGZ Electrode, Ion-Specific, Chloride
Reason for recall: The values reported by the chloride sensors may report erroneous values below specification on aqueous controls and potentially with patient samples of whole blood and serum/plasma.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: OPTIMedical Systems sent an "URGENT: MEDICAL DEVICE RECALL" letter dated March 15, 2011 to all affected customers. The letter describes the product, problem, and actions to be taken by the customers. Customers were notified by letter via e-mail and fax. Customers were instructed to discontinue use of the product and to return any unused product to OPTI Medical Systems, Inc. Customers outside the U.S. were instructed to destroy unused product and certify the destruction on the enclosed Recall Response Card. The Response Card was to be completed and returned to OPTI Medical Customer Service via fax. OPTI Medical Systems will replace the cassettes they have with product from another lot. Customers were instructed to contact the Technical Support Department at 1-800-490-6784 for questions relating to this notice.
Quantity in commerce: 86 boxes (25 units (per box)
Distribution: Worldwide Distribution-- USA (nationwide) including states of CA and VA, and countries of India, Lebanon, Philippines, Sweden, Venezuela and Vietnam.
Product codes and lots: Lot numbers 038811 and 102812

Product code CGZ

K052027Class IIOpti Lion Electrolyte Analyzer, Model Gd7200Osmetech, Inc. / cleared 2005-09-29

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)