International Medical Devices Database

Manufacturer Address
Osmetech Inc, 235 Hembree Park Dr, Roswell GA 30076-5700
Source
USFDA
1 Event
- Recall of Device Recall Osmetech OPTICCA, EGlu Cassettes

One device in the database

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.

One manufacturer with a similar name

Learn more about the data here

Osmetech Inc

Manufacturer Parent Company (2017)
Osmetech
Source
SATP

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Disclaimer

Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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