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Device Recall IMMULITE /IMMULITE 1000 OMMA (CA125)
Model / Serial
OM-MA (CA125), OM-MA (CA125) (IMMULITE/IMMULITE 1000, LKOP1), (IMMULITE 2000/IMMULITE 2000 XPi, LKOP2) Lot codes: CA125 (OM-MA) 0211 0212 0213
Product Classification
Immunology and Microbiology Devices
Device Class
2
Implanted device?
No
Distribution
Nationwide and Canada, Mexico, and Thailand
Product Description
IMMULITE ¿ /IMMULITE ¿ 1000 OM-MA (CA125)
Manufacturer
Siemens Healthcare Diagnostics, Inc.
1 Event
Recall of Device Recall IMMULITE /IMMULITE 1000 OMMA (CA125)
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Manufacturer
Siemens Healthcare Diagnostics, Inc.
Manufacturer Address
Siemens Healthcare Diagnostics, Inc., 511 Benedict Ave, Tarrytown NY 10591-5005
Manufacturer Parent Company (2017)
Siemens Ag
Source
USFDA
Language
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