Recall Z-1064-04 ยท CGA Glucose Oxidase, Glucose
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.
| Date | Jun 22, 2004 |
| Status | Terminated |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.