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
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
Osmetech Inc
Lot Codes / Batch Numbers
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.
Products Sold
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.
Osmetech Inc is recalling Osmetech OPTI-CCA Blood Gas Analyzer, Single Use, BP7564 OPTIE-Glu Cassettes.The cassettes are label due to In some cases patient samples with high glucose concentrations, above the reportable range of the OPTI-CCA Analyzer, may be erroneously reported as 'L. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
In some cases patient samples with high glucose concentrations, above the reportable range of the OPTI-CCA Analyzer, may be erroneously reported as 'Low'.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026