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Recall Observatory FDA recall evidence

Device product

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

Z-0020-2014

August 12, 2013

Class II

Product summary

Firm
Abbott Laboratories, Inc
Event
Event 66047
Status
Terminated
Classification
Class II
Quantity
7213
Official record key
device-enforcement:Z-0020-2014

Official wording

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

Code information: For List Number: 7D71-22, Lot Numbers 64736UN12 (Exp Date on Label is 14 JAN 2014), 03991UN13 (Exp Date on Label is 01 APR 2014), and 51611UN13 (Exp Date on Label is 13 JUL 2014). For List Number: 7D71-31, Lot Numbers 74805UN12 (Exp Date on Label is 14 JAN 2014) and 03992UN13 (Exp Date on Label is 01 APR 2014).

Distribution pattern: 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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