FDA-Device2013-10-23Class II

Clinical Chemistry Phosphorus Reagent The Phosphorus assay is used for the quantitation of phosphorus in human serum, plasma, or urine.

Abbott Laboratories, Inc
Hazard

Reagent lots 64736UN12, 03991UN13, 51611UN13, 74805UN12, and 03992UN13 have incorrect expiration dates assigned by Supplier.

Sold states
Worldwide distribution: US (nationwide) including Puerto Rico and countries of: Albania, Algeria, Argentina, Austria, Australia, Azerbaijan, Bangladesh, Bahamas, Belgium, Bosnia & Herzegovina, Brazil, Bulgaria, Burkina, Canada, Cayman Islands, Chile, China, Columbia, Croatia, Curacao, Cyprus, Czech Republic, Denmark, Dominican Republic, El Salvador, Egypt, Estonia, Ethiopia, Finland, France, Germany, Greece, Guatemala, Hong Kong, India, Iraq, Ireland, Israel, Italy, Ivory Coast, Jamaica, Jordan, Kazakhstan, Kenya, Kuwait, Latvia, Lebanon, Libya, Lithuania, Luxembourg, Malaysia, Mali, Mauritania ,Mexico, Moldova, Morocco, Netherlands, New Zealand, Norway, Oman, Pakistan, Panama, Paraguay, Philippines, Poland, Portugal, Qatar, Republic of Yemen, Romania, Russia, Saudi Arabia, Senegal, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Tajikistan, Taiwan, Tanzania, Thailand, Trinidad & Tobago, Tunisia, Turkey, Turks and Caicos, United Arab Emirates, United Kingdom, Uruguay and Vietnam.
Affected count
7213
Manufactured in
1921 Hurd Dr, Irving, TX, United States
Products
Clinical Chemistry Phosphorus Reagent The Phosphorus assay is used for the quantitation of phosphorus in human serum, plasma, or urine.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0020-2014

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