An internal biomérieux investigation was performed with results as follows: for all samples, the customer reported that direct inoculation, nylon flocked swabs with transport medium (eswab) was used.Each specimen showed growth of typical green colonies on the chromid® mrsa plates at 24 hours of incubation at 35°c.The customer reported minimum inhibitory concentrations of <=2 mg/l and negative results for plp2a.The customer reported that detection of plp2a was performed using immuno-chromatography.The customer did not retain the strains in question, it was therefore not possible to include them in the investigation.At the time of the investigation lot number 1005719760 had already expired, it was therefore not possible to analyze the retained biomérieux samples.The investigation consisted of a review of complaints registered for the impacted lot number and a review of the lot number file.In conclusion, complaint trend analysis for the impacted lot number indicated that no other complaints were registered for this lot.A review of the impacted lot number file indicated that the product conformed with specifications.The patient strains in question were not available to test as part of the investigation, it was therefore not possible to determine the root cause of the issue observed by the customer.The customer reported that test results for the patient strains were negative for plp2a, the limitations section of the package insert states " certain strains of s.Aureus which do not have the mec a gene may develop typical colonies on this type of medium after 24 or 48 hours of incubation." corrective and preventive actions will not be implemented as the product is performing within specification.
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