Z-1083-2010

OPTI LION Cassettes, E-Plus, Model BP7507 (25 per box), OSME TECH critical care. Intended to be used for the...

Name: Z-1083-2010 OPTI LION Cassettes, E-Plus, Model BP7507 (25 per box), OSME TECH critical care. Intended to be used for the...
Creator: OPTI Medical Systems, Inc
Published: 2009-04-20
License: https://open.fda.gov/license/

Opti Medical Systems Inc / initiated 2009-04-20 / Terminated / root cause: manufacturing process

FDA source

OPTI Medical Systems, Inc began a recall of OPTI LION Cassettes, E-Plus, Model BP7507 (25 per box), OSME TECH critical care. Intended to be used for the measurement of sodium, potassium, chloride... on 2009-04-20. The reason FDA records is "Outer box labeling shows an incorrect storage temperature range". 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-1083-2010
Status: Terminated
Initiated: 2009-04-20
Posted: 2010-03-11
Terminated: 2012-04-17
Recalling firm: Opti Medical Systems Inc
Product: OPTI LION Cassettes, E-Plus, Model BP7507 (25 per box), OSME TECH critical care. Intended to be used for the measurement of sodium, potassium, chloride, ionized calcium and pH in samples of whole blood, serum and plasma.
Product code: CGZ Electrode, Ion-Specific, Chloride
Reason for recall: Outer box labeling shows an incorrect storage temperature range.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: OPTI Medical Systems, Inc. issued a "Medical Device Correction" letter dated April 20, 2009. Consignees were instructed on how to corrected the affected product and were asked to return a completed Correction Response Card. For further information, contact OPTI Medical Systems, Inc. at +01 770 510 4444 (outside US) or 1-800-490-6784 (US).
Quantity in commerce: 127 boxes of 25 cassettes each for a total of 3175 cassettes.
Distribution: Worldwide Distribution -- United States (CA, KY, MA and OK), Djouti (Africa), Egypt, Guatemala, India, Iraq, Pakistan, United Arab Emirates and Vietnam.
Product codes and lots: Lot numbers: 904801, 904803 and 915800.

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)