FDA Medical Device Recalls (openFDA)
OPTI Medical Systems, Inc: 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.
- Recall number
- Z-1083-2010
- 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.
- Status
- Terminated
- Initiated
- 2009-04-20
- Posted
- 2010-03-11
- Terminated
- 2012-04-17
- Reason
- Outer box labeling shows an incorrect storage temperature range.
- 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
- 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.
- Lot, serial or model codes
- Lot numbers: 904801, 904803 and 915800.
- 510(k) numbers
- ["K052027"]
- PMA numbers
- not on file
- Product code
- CGZ
- Firm FEI
- 3004102403
- Firm city
- Roswell
- Firm state
- GA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28