This report was initially submitted following notification by an industry customer in germany of a misidentification of serratia marcescens as serratia liquefaciens when testing a qc strain with api® rapid 20 e 25strips (ref.20701) - lot 1005589130.The customer stated they tested a known serratia marcescens strain and received an identification of 95.5% s.Liquefaciens (and 3.9% s.Marcenscens).Sequencing methodology confirmed the species serratia marcescens.Biomérieux internal investigation was conducted.Review of the complaint identified: the tested strain was obtained from a contamination.The customer does not test the recommended strains for qc.The customer performed retest with another rapid 20 e lot number 1006885690.Expiration date 22-apr-2020 and obtained a good identification to serratia marcescens.Complaints trend analysis identified one other complaint on rapid 20 e reference 20701 for the serratia species.This complaint led to an investigation; however, customer problem wasn't reproduced internally.No other complaint was registered on the lot number 1005589130.Review of the lot record indicated no batch event impacting the performance of the lot 1005589130.As api rapid 20 e lot number 1005589130 was expired at the time of investigation, no further investigation was possible.
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