Medical device manufacturer, Roche, has issued a medical device safety alert concerning its Elecsys CA 19-9 with reagent lot 416245 on cobas e 801 [Production Identifier: 07027028 190].
The manufacturer recently received an increased number of complaints concerning non-reproducible elevated results for the affected product.
The issue appears as follows:
- Either result of multiple determinations is non-reproducible elevated compared to the other results of the same sample aliquot.
- The issue has been observed with both plasma and serum samples.
- The increased frequency of non-reproducible elevated results has only been reported for reagent lot 416245. The issue is reagent lot-specific and not related to cobas e 801 instrument.
According to the manufacturer, the issue can lead to non-reproducible elevated CA 19-9 results and therefore affect clinical interpretation.
The manufacturer's investigations revealed that the occurrence of non-reproducible falsely elevated results is related to a contamination with magnetic/paramagnetic particles (no beads) that occurred during the filling process for cobas e 801 only. Thus, reagents filled for cobas e 411/e 601/e 602 are unaffected.
The manufacturer has already taken immediate corrections and its investigations are currently ongoing to:
- Establish methods for recognition of affected lots during the filling process
- Eliminate the contamination with particles within the filling process
- Monitor and identify if other Elecsys assays are affected by the issue. So far, a similar issue was observed with certain lots of Elecsys Troponin T hs on cobas e 801. At this point, there is no indication that further Elecsys assays (beyond Troponin T hs and CA 19-9) are affected by the issue.
Affected users are advised to take the following actions:
- Only Elecsys CA 19-9 (07027028 190) lot 416245 (which runs on cobas e 801) is affected.
- Wherever possible, they are asked to switch Elecsys CA 19-9 from cobas e 801 to cobas e 411/e 601/e 602. All reagent lots CA 19-9 (11776193 122) running on cobas e 411/ e 601/ e 602 can be used without restrictions. Reagent lot 375128 Elecsys CA 19-9 (11776193 122) running on cobas e 411/ e 601/ e 602 should not be used in combination with PreciControl Tumormarker (11776452 122) lot 415249. All other combinations of Elecsys CA 19-9 reagent lot/ PreciControl Tumormarker running on cobas e 411/e 601/e 602 can be used without any restrictions.
- In case switch from cobas e 801 to cobas e 411/ e 601/ e 602 is not possible, those using cobas e 801 are advised to perform the following actions for the affected lot: ²
- In order to reduce the frequency of non-reproducible elevated results, ensure not to invert or shake the ePacks prior to loading on to the analyzer and discard each ePack of the affected lot after the first 200 determinations.
- Perform double determinations from the same tube for all results ≥ 37 U/ml CA 19-9 in order to increase the detectability of possible non-reproducible elevated results.
According to the local supplier, the affected products are distributed in Hong Kong.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 24 January 2020