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Devices
Device Recall MIRA
Model / Serial
Lots 646340, 650984, 651640 and 653292.
Product Classification
Hematology and Pathology Devices
Device Class
2
Implanted device?
No
Distribution
Nationwide.
Product Description
Roche ULTIMATE 3 HBA1C test kit for use with MIRA analyzers; catalog number 20755648322.
Manufacturer
Roche Diagnostics Corp.
1 Event
Recall of Device Recall MIRA
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Manufacturer
Roche Diagnostics Corp.
Manufacturer Address
Roche Diagnostics Corp., 9115 Hague Rd, Indianapolis IN 46256-1025
Source
USFDA
One device with a similar name
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Device Recall MIRA
Model / Serial
Lots 645515, 650134, 655120, 660108.
Product Classification
Hematology and Pathology Devices
Device Class
2
Implanted device?
No
Distribution
Nationwide.
Product Description
Roche ULTIMATE 5 HBA1C test kit for use with MIRA analyzers; catalog number 20755656322.
Manufacturer
Roche Diagnostics Corp.
Language
English
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