FDA
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.
In some cases patient samples with high glucose concentrations, above the reportable range of the OPTI-CCA Analyzer, may be erroneously reported as 'Low'.
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.