Devices

Device Recall Roche Molecular Systems cobas 4800 System

Model / Serial
Lot / SN : 477415,477416, 477898, and 477899
Product Classification
Clinical Chemistry and Clinical Toxicology Devices
Device Class
2
Implanted device?
No
Distribution
Nationwide Distribution including Puerto Rico and the states of MO, NE, CO, MT, NJ, FL, WA, TX, GA, NY, KS, NH, VA, HI, PA, MI, IA, CA, NC, AZ, UT, LA, IL, TN, ME, MN, KY, CT, OR, NV, AL and NM.
Product Description
Roche Molecular Systems cobas x 480 System 50 mL reagent reservoir, Catalog number 05232732001. Used with the cobas¿ CT/NG 4800 System, for in vitro diagnostics.
Manufacturer
Roche Diagnostics Operations, Inc.
1 Event
- Recall of Device Recall Roche Molecular Systems cobas 4800 System

Manufacturer

Roche Diagnostics Operations, Inc.

Manufacturer Address
Roche Diagnostics Operations, Inc., 9115 Hague Rd, Indianapolis IN 46256-1025
Manufacturer Parent Company (2017)
Roche Holding AG
Source
USFDA

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