FDA Medical Device Recalls (openFDA)
Osmetech Inc: Osmetech OPTI-CCA Blood Gas Analyzer, Single Use, BP7564 OPTIE-Glu Cassettes.The cassettes are labeled, Roche OPTICCA Cassettes E-Glu. There are 25 cassettes in each box.
- Recall number
- Z-1064-04
- Recalling firm
- Osmetech Inc
- Product
- Osmetech OPTI-CCA Blood Gas Analyzer, Single Use, BP7564 OPTIE-Glu Cassettes.The cassettes are labeled, Roche OPTICCA Cassettes E-Glu. There are 25 cassettes in each box.
- Status
- Terminated
- Initiated
- 2004-06-22
- Posted
- not on file
- Terminated
- 2005-01-12
- Reason
- In some cases patient samples with high glucose concentrations, above the reportable range of the OPTI-CCA Analyzer, may be erroneously reported as 'Low'.
- Root cause
- Other
- Action
- Consignees were notified by letter on 6/22/04. A separate Recall Notice was mailed to distributors outside the United States with instructions on issuing the recall notice to their affected customers in the appropriate language.
- Quantity
- 1087 boxes
- Distribution
- Nationwide and Argentina, Austria, Bolivia, France, Greece, Germany, Korea, India, Italy, Jordan, Netherlands, Sweden, Switzerland.
- Lot, serial or model codes
- All OPTI-CCA Analyzers with software version 2.20 through 2.24 are affected. Catalog Number BP7564, Lot #351601, 401600, 401601, 405600, 405601, 406600, 406601, 405600, 405601, 410600, 412600, 415600, 415601, 417600, 419600, 419601, 419602 and 419603.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- CGA
- 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