Devices

Device Recall Osmetech OPTICCA, EGlu Cassettes

Model / Serial
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.
Product Classification
Clinical Chemistry and Clinical Toxicology Devices
Device Class
2
Implanted device?
No
Distribution
Nationwide and Argentina, Austria, Bolivia, France, Greece, Germany, Korea, India, Italy, Jordan, Netherlands, Sweden, Switzerland.
Product Description
Osmetech OPTI-CCA Blood Gas Analyzer, Single Use, BP7564 OPTI¿E-Glu Cassettes.The cassettes are labeled, Roche OPTICCA Cassettes E-Glu. There are 25 cassettes in each box.
Manufacturer
Osmetech Inc
1 Event
- Recall of Device Recall Osmetech OPTICCA, EGlu Cassettes

Manufacturer

Osmetech Inc

Manufacturer Address
Osmetech Inc, 235 Hembree Park Dr, Roswell GA 30076-5700
Source
USFDA

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