During Ortho's internal release testing of lot 34-1345, an issue was confirmed up to 6% of reagent packs may generate the biased results. Subsequent testing also confirmed atypical drift on results obtained from affected reagent packs. As the issues were detected in the most recent lot, Ortho's investigation is on-going. Release testing performed on reagent lot 34-1345 identified this issue. In an abundance of caution, the required actions are applicable to all lots within expiry (listed in the communication) as well as future lots until the laboratory receives an additional notification from ortho. However, while data is limited, a review of the release testing indicated no other lots were impacted. Recall start date: April 20, 2023
RecallTracker