Reported Jul 4, 2012 · 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…
Abbott Laboratories
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Abbott Laboratories · 100 Abbott Park Rd · Abbott Park, IL · 60064-3502
Is this the product you have?
ARCHITECT CA 19-9XR Reagent KitARCHITECT CA 19-9 Reagent Kitlist 291-20 (4 x 100 tests)2K91-25 and 2K91-27 (1 x 100 tests)
- Product UsageThe 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
- Lot codes and dates
lot 08849M500 exp. 10/13/2012lot 08851M500 exp. 10/13/2012lot 08852M500 exp. 11/30/2012lot 08853M500 exp. 11/30/2012lot 10040M500 exp. 11/30/2012and lot 10122M500 exp. 11/30/2012
- Amount recalled
- 316 kits - USA, 8,356 kits ROW
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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