H6: investigation summary: the complaint investigation for contamination when using bd max exk dna-3 usa kit (ref #442821) from lot 2025615 was performed by the review of manufacturing records, analysis of customer data and verification of complaints history.Review of the manufacturing records of the bd max exk dna-3 usa kit lot indicated that the lot was manufactured according to specifications and met performance requirements.Customer complained about widespread contamination across several kits of bd max exk dna-3 usa kit lot 2025615.According to customer, positive e.Faecalis results were obtained on blank and environmental monitoring samples.Customer provided runs for investigation (runs 1620 and 1627 from instrument ct1313).In run #1627, there is one blank sample positive for e.Faecalis and in run #1620, there are two e.Faecalis positive results (position a5 and position a7).Manual pcr curves adjudication of the three e.Faecalis positive results in the runs provided revealed late and low, but true amplification of the target.Nevertheless, manual curve adjudication has limitations and visual examination of pcr curves for low signal is a conservative assessment of the data.The bd max exk dna-3 is an open system reagents kit intended to extract dna from swab specimens in universal transport media (utm) or neat urine specimens.The bd max exk dna-3 has not been validated for use with any specific test method, and as such, it is not possible for bd to test for all possible presence of target that could potentially impact assays developed by customers.Customers need to validate and use appropriate controls, in accordance with country, federal, provincial, state, local and/or accrediting organization guidelines, regulations and standards.The investigation conducted by bd identified the root-cause of these positive e.Faecalis results as contaminated lots of enzymes used in the manufacturing of the extraction tubes.The investigation also allowed to detect contamination of m.Morganii target.The enzyme supplier was informed of this contamination and an investigation is ongoing by the supplier.There is no indication of an increase in complaints for contamination on bd max exk dna-3 usa kit lot 2025615.The root cause was identified as a raw material contamination, investigation is still ongoing to determine the exact cause at the supplier.Bd confirms the complaint based on the investigation that was performed.
|