Devices

Device Recall ARCHITECT Folate Reagent

Model / Serial
Product Control/Lot # (For List #07K60-20): 42908JN00, 42964JN00 and 42905JN00; (For List #07K60-25): 42909JN00, 42965JN00 and 42906JN00; (For List #07K60-30): 42910JN00, 42966JN00, 42907JN00, and 42931JN00.
Product Classification
Clinical Chemistry and Clinical Toxicology Devices
Device Class
2
Implanted device?
No
Distribution
Folate Reagent distributed to the following countries: Australia, Austria, Belgium, Bosnia and Herzegovina, Brazil, Canada, Chile, China, Colombia, Croatia, Czech Republic, Denmark, Dominican Republic, Finland, France, Greece, Hungary, Ireland, Israel, Italy, Jordan, Lebanon, Luxembourg, Netherlands, New Zealand, Norway, Oman, Peru, Poland, Portugal, Qatar, Russia, Saudi Arabia, Serbia and Montenegro, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Trinidad and Tobago, Turkey, UAE, United Kingdom. No US distribution.
Product Description
ARCHITECT Folate Reagent, for in vitro diagnostics, List Numbers 07K60-20 (4 x 100 test kits), 07K60-25 (100 test kits)and 07K60-30 (4 x 500 test kits); manufactured by Abbott Ireland Diagnostic Division, Lisnamuck, Longford, Ireland.
Manufacturer
Abbott Laboratories, Inc
1 Event
- Recall of Device Recall ARCHITECT Folate Reagent

Manufacturer

Abbott Laboratories, Inc

Manufacturer Address
Abbott Laboratories, Inc, 1921 Hurd Drive, PO Box 152020, Irving TX 75038
Source
USFDA

One device with a similar name

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Device Recall ARCHITECT Folate Reagent Kit

Model / Serial
lot numbers 21082M200, 22024M100, 21082M201, 22024M101, 16603M200, and 22025M100
Product Classification
Clinical Chemistry and Clinical Toxicology Devices
Device Class
2
Implanted device?
No
Distribution
Canada, Singapore, New Zealand, Germany, Hong Kong, Japan, and Australia
Product Description
ARCHITECT Folate Reagent Kit, list 6C12-20 ( 4 x 100 tests), 6C12-25 (1 x 100 tests) and 6C12-30 (4 x 500 tests), Abbott Laboratories, Abbott Park, IL 600064 U.S.A.
Manufacturer
Abbott Laboratories MPG

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Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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