Devices

Device Recall CA 153 Calibrator Pack

Model / Serial
list 9C08-01, lot 88127M100
Product Classification
Immunology and Microbiology Devices
Device Class
2
Implanted device?
No
Distribution
Nationwide and Ecuador, England, Hong Kong, Chile, Japan, Canada, Singapore, Australia, Pakistan, Argentina, Thailand, Aruba, Korea and Jamaica.
Product Description
CA 15-3 Calibrators, list 9C08-01; the pack contains six 4-mL bottles of 115D8:DF3 reactive determinants prediluted in TRIS buffer with protein stabilizers to yield the following assay values: A - 0 u/mL, B - 15 U/mL, C - 60 U/mL, D - 120 U/mL, E - 180 U/mL and F - 250 U/mL; Abbott Laboratories, Abbott Park, IL 60064
Manufacturer
Abbott Laboratories HPD/ADD
1 Event
- Recall of Device Recall CA 153 Calibrator Pack

Manufacturer

Abbott Laboratories HPD/ADD

Manufacturer Address
Abbott Laboratories HPD/ADD, 100/200 Abbott Park Road, Abbott Park IL 60064
Source
USFDA

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