Abbott Recalls Architect CA 19-9 Reagent Kits Due to Result Shifts
Abbott Laboratories is recalling specific lots of ARCHITECT CA 19-9XR Reagent Kits because they are causing an upward shift in patient test results.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text does not report any hospitalizations, injuries, or illnesses. The hazard is a potential for inaccurate test results (upward shift) rather than a direct physical injury or high-risk pathogen, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Abbott Laboratories is recalling specific lots of ARCHITECT CA 19-9XR and ARCHITECT CA 19-9 Reagent Kits. The recall involves 316 kits in the United States and 8,356 kits in other countries. The affected lots are 08849M500, 08851M500, 08852M500, 08853M500, 10040M500, and 10122M500, with expiration dates ranging from October 13, 2012, to November 30, 2012.
The recall was initiated because the reagent lots are demonstrating an upward shift in patient results. This shift could affect the accuracy of quantitative determinations for 1116-NS-19-9 reactive determinants in human serum or plasma. The Abbott Controls used for quality assurance do not detect this upward shift and will test within range, meaning the issue may not be caught by standard control checks.
The affected products are distributed worldwide, including in numerous U.S. states and international locations. The ARCHITECT CA 19-9XR assay is used as an aid in the management of pancreatic cancer patients in conjunction with other clinical methods. Healthcare facilities and laboratories should stop using the affected lots and contact Abbott Laboratories for further instructions.
The recalled product
- 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-
- Manufacturer
- Abbott Laboratories
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (6)
- 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
Distribution
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