Z-1904-2012Class II

ARCHITECT CA 19-9XR Reagent Kit; ARCHITECT CA 19-9 Reagent Kit, list 291-20 (4 x 100 tests), 2K91-25 and...

Name: Z-1904-2012 ARCHITECT CA 19-9XR Reagent Kit; ARCHITECT CA 19-9 Reagent Kit, list 291-20 (4 x 100 tests), 2K91-25 and...
Creator: Abbott Laboratories
Published: 2012-05-30
License: https://open.fda.gov/license/

Abbott Medical / initiated 2012-05-30 / Terminated / root cause: manufacturing process

FDA source

Abbott Laboratories began a recall of 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... on 2012-05-30. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1904-2012
Classification: Class II
Status: Terminated
Initiated: 2012-05-30
Posted: 2012-06-29
Terminated: 2016-12-23
Recalling firm: Abbott Medical
Product: 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.
Product code: NIG System, Test, Carbohydrate Antigen (Ca19-9), For Monitoring And Management Of Pancreatic Cancer
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.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
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.
Quantity in commerce: 316 kits - USA, 8,356 kits ROW
Distribution: 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.
Product codes and lots: lot 08849M500 exp. 10/13/2012; lot 08851M500 exp. 10/13/2012; lot 08852M500 exp. 11/30/2012; lot 08853M500 exp. 11/30/2012; lot 10040M500 exp. 11/30/2012; and lot 10122M500 exp. 11/30/2012

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1904-2012
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1904-2012	Class II	Terminated	Voluntary: Firm initiated	2012-07-04	2012-06-28

Product code NIG

K052000Class IIArchitect Ca 19-9Xr AssayFujirebio Diagnostics,Inc. / cleared 2005-10-25

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)