Terminated

ARCHITECT CA 19-9XR Reagent Kit; ARCHITECT CA 19-9 Reagent Kit, list 291-20 (4 x 100 tests), 2K91-25 and 2K91-27 (1 x 100 tests); Product Usage: The ARCHITECT CA 19-9XR assay is a chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of 1116-NS-19-9 reactive determinants in human serum or plasma on the ARCHITECT i System. The ARCHITECT CA-19-9XR assay is to be used as an aid in the management of pancreatic cancer patients in conjunction with other clinical methods.

FDA Recall Z-1904-2012 · Posted 2012-06-29

Recalling FirmAbbott Laboratories

Recall StatusTerminated

Product CodeNIG

Date Initiated2012-05-30

Date Terminated2016-12-23

Product Quantity316 kits - USA, 8,356 kits ROW

Reason for Recall

The six ARCHITECT CA 19-9XR reagent lots are demonstrating a shift up in patient results. The Abbott Controls however do not detect the upward shift and will test within range.

Firm Action

The firm, Abbott Laboratories, sent a "Product Recall Immediate Action Required" letter dated May 30, 2012 to all Architect CA 19-9XR customers who received the affected reagent lots. The customers were directed to immediately discontinue use and destroy any remaining inventory of the lots listed; to review the patient results obtained with the affected lots with the treating physician or heath care provider to ensure they are aware of the potential analytical issue and can determine whether re-evaluation of the patient is necessary; to forward a copy of the letter to any laboratory to whom they may have forwarded the reagent; and to retain a copy of the letter for their records and to complete and return the Customer Reply Form via fax to: 1-800-777-0051 or e-mail: [email protected]. For questions were call your local Customer Service representative or call the field action coordinator at 847-938-1923.

Root Cause

Nonconforming Material/Component

Distribution Pattern

Worldwide Distribution - US (nationwide) the states of: Alabama, Arkansas, Arizona, California, Florida, Iowa, Indiana, Louisiana, Michigan, Minnesota, New Jersey, Nevada, New York, Ohio, Oklahoma, Pennsylvania, South Dakota, Texas, Virginia, Washington, including Puerto Rico, and the countries of Algeria, Argentina, Australia, Austria, Azerbaijan, Bahrain, Barbados, Belarus, Belgium, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Croatia, Czech Republic, Ecuador, Egypt, Estonia, Finland, France, Gaza & Jericho, Germany, Greece, Guatemala, Hong Kong, Hungary, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Kyrgyzstan, Latvia, Lebanon, Lithuania, Luxembourg, Malaysia, Mexico, Montenegro, Morocco, Netherlands, New Zealand, Oman, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Republic of Yemen, Romania, Russia, Saudi Arabia, Senegal, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Thailand, Togo, Tunisia, Turkey, United Arab Emirates, United Kingdom, Uruguay, Venezuela and Vietnam.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K052000ARCHITECT CA 19-9XR ASSAYFujirebio Diagnostics,Inc. · 2005-10-25

Official Source

View FDA Recall →

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