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Devices
Cobas
Model / Serial
Lot #s: 70712A (6 kits); 70601W (76 kits); 70713A (4 kits); 70718A (50 kits); and 70809A (kits were not distributed to end users).
Product Classification
Immunology and Microbiology Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide distribution. Austria, Denmark, Germany, Singapore, Netherlands, Hong Kong, and Switzerland. US product is not affected.
Product Description
Nucleic Acid test intended for screening for MRSA/SA. Each kit has 20 tubes. in vitro diagnostic.
Manufacturer
Roche Molecular Systems, Inc.
1 Event
Recall of Cobas
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Manufacturer
Roche Molecular Systems, Inc.
Manufacturer Address
Roche Molecular Systems, Inc., 1080 US Highway 202 S, Branchburg NJ 08876-3733
Manufacturer Parent Company (2017)
Roche Holding AG
Source
USFDA
918 devices with a similar name
Learn more about the data
here
Neonatal Bilirubin: Limitations on Clinical Analysis of Bilirubin on the cobas b 123 POC System.
Model / Serial
Manufacturer
Roche
"cobas b 123 FLUID PACK 200 cobas b 123 FLUID PACK 400 cobas b 123 FLUID PACK COOX 200 cobas b 12...
Model / Serial
Manufacturer
Roche Diagnostics
cobas b 123 FLUID PACK 200, 400, cobas b 123 FLUID PACK COOX 200, 400, 700
Model / Serial
Manufacturer
Roche Diagnostics GmbH
cobas® EGFR Mutation Test v2
Model / Serial
Manufacturer
Roche Diagnostics
cobas b 123 < 3 > POC system, cobas b 123 < 4 > POC system
Model / Serial
Manufacturer
Roche
913 more
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