The investigation determined that there was reagent contamination, which occurred during the filling process of the elecsys ca 19-9 reagent cassettes lot number 416245 for the cobas e 801 module only.The issue is related to contamination of the reagent with magnetic particles.A replacement lot is not currently available.Roche has provided two work around options to customers.The first work around is customers may discontinue running the elecsys ca 19-9 assay on the e801 and instead run the ca 19-9 assay on the cobas e 411 analyzer, cobas e 601 and 602 modules, or the modular analytics e 170 module.The second work around is customers can continue to run the ca 19-9 assay on the e801 and repeat all results =37 u/ml within 2 hours.Customers are also instructed to use only the first 200 determinations of the 300 test cobas e pack.Instructions for implementing these work arounds were communicated to customers by customer notification.This event occurred in (b)(6).
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The initial reporter stated they received a discrepant result for one patient sample tested with elecsys ca 19-9 immunoassay on a cobas 8000 e 801 module.It was asked, but it is not known if an incorrect result was reported outside of the laboratory.The sample initially resulted with a ca 19-9 value of 46.6 u/ml.The sample was repeated, resulting with a value of 2.14 u/ml.The repeat result was believed to be correct based on the patient's previous results.The serial number of the customer's e 801 analyzer is (b)(4).
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