Devices

Device Recall ARCHITECT LH Reagent

Model / Serial
lot numbers 33198M200 and 41861M100, 33198M201, and 33871M100. All lots expire 6/16/2007.
Product Classification
Clinical Chemistry and Clinical Toxicology Devices
Device Class
1
Implanted device?
No
Distribution
Worldwide distribution including U.S.A., Puerto Rico, Canada, Mexico, Venezuela, Colombia, Chile, Uruguay, Argentina, Brazil, Dominican Republic, Germany, Japan, Singapore, Hong Kong, Taiwan, Thailand, South Korea, Australia, New Zealand and Panama.
Product Description
ARCHITECT LH Reagent, each kit contains bottles of Anti-Beta LH coated Microparticles and bottles of Anti-Alpha LH acridinium-labeled Conjugate; list numbers 6C25-22 (4 x 100 tests), 6C25-27(1 x 100 tests), and 6C25-30 (4 x 500 tests); Abbott Laboratories, Abbott Park, IL 60064-3500
Manufacturer
Abbott Laboratories MPG
1 Event
- Recall of Device Recall ARCHITECT LH Reagent

Manufacturer

Abbott Laboratories MPG

Manufacturer Address
Abbott Laboratories MPG, 100 Abbott Park Rd, Abbott Park IL 60064-3502
Source
USFDA

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