Recall Z-1904-2012
Abbott Laboratories · initiated May 30, 2012
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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.
Codes / 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
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.
FDA-determined cause: Nonconforming Material/Component
Action taken
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: QAGCO@abbott.com. For questions were call your local Customer Service representative or call the field action coordinator at 847-938-1923.
Details
- Recall number
- Z-1904-2012
- Initiated
- May 30, 2012
- Posted by FDA
- June 29, 2012
- Terminated
- December 23, 2016
- Product code
- NIG – System, Test, Carbohydrate Antigen (Ca19-9), For Monitoring And Management Of Pancreatic Cancer
- Quantity
- 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…
- Recalling firm
- Abbott Laboratories, Abbott Park, IL