Devices

Device Recall iChem 10 SG Urine Chemistry Strips

Model / Serial
510033A, expiration 2015-03 510034A, expiration 2015-04 510035A, expiration 2015-07 510035B, expiration 2015-09
Product Classification
Clinical Chemistry and Clinical Toxicology Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide Distribution -- US, Brazil, Canada, Chile, Ecuador, France, Germany, Greece, Italy, Kuwait, Luxembourg, Malaysia, Philippines, Portugal, Puerto Rico, Singapore, Spain, Switzerland, Turkey, and United Arab Emirates.
Product Description
iChem 10 SG Urine Chemistry Strips, PN 800-7005. || Intended for the in vitro measurement of glucose, protein, bilirubin, urobilinogen, pH, specific gravity, blood, ketones, nitrite, leukocyte esterase, ascorbic acid, and color.
Manufacturer
Beckman Coulter Inc.
1 Event
- Recall of Device Recall iChem 10 SG Urine Chemistry Strips

Manufacturer

Beckman Coulter Inc.

Manufacturer Address
Beckman Coulter Inc., 250 S Kraemer Blvd, Brea CA 92821-6232
Manufacturer Parent Company (2017)
Danaher Corporation
Source
USFDA

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