Devices

Device Recall Seradyn QMS Vancomycin

Model / Serial
All lots (lots 501930, 502063, 502074, 600432, 601166, 601207, 602556, 603076, 603801, 603312, 700657 and 703027).
Product Classification
Clinical Chemistry and Clinical Toxicology Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide Distribution --- USA including states of California and New York, and countries of Australia, Belgium, Canada, Finland, Germany, Ireland, Japan, Spain and United Kingdom.
Product Description
Seradyn QMS Vancomycin reagents, Part Number: 0373589. Seradyn, Inc, Indianapolis, IN.
Manufacturer
Seradyn, Inc.
1 Event
- Recall of Device Recall Seradyn QMS Vancomycin

Manufacturer

Seradyn, Inc.

Manufacturer Address
Seradyn, Inc., 7998 Georgetown Rd, Indianapolis IN 46268-5631
Manufacturer Parent Company (2017)
Thermo Fisher Scientific Inc
Source
USFDA

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