Terminated

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

FDA Recall Z-0020-2014 · Posted 2013-10-17

Recalling FirmAbbott Laboratories, Inc

Recall StatusTerminated

Product CodeCEO

Date Initiated2013-08-12

Date Terminated2015-04-06

Product Quantity7213

Reason for Recall

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

Firm Action

The firm, Abbott Laboratories, sent a "PRODUCT CORRECTION" letter dated August 12, 2013 to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to update existing inventory and manually track the implanted lots with the corrected expiration dates listed in the letter; retain a copy of letter and if you have forwarded any of the lots listed to another laboratory, provide a copy of the letter to them. If you or any of your healthcare providers you serve have any questions regarding this information, U.S. Customers please contact Customer Service at 1-877-4ABBOTT (422-2688). Customers outside the U.S., please contact your local area customer service.

Root Cause

Error in labeling

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K981759PHOSAbbott Laboratories · 1998-06-16

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.