[91929072]
A customer from (b)(6) notified biom? Rieux of discrepant results when testing a quality control sample using chromid? Strepto b agar (reference 43461). The customer reported that they repeated the quality control test using the same quality control sample and their second lot of chromid? Strepto b agar reference 43461 (lot 1005925100) and had obtained the same discrepant result. This second event has been recorded under (b)(4). The customer stated that they had inoculated strep. Agalactiae atcc 13813 quality control sample directly in the agar plates and that after 18-24 hours incubation under co2, they had observed the expected characteristic bacterial growth (red colonies). The customer reported that in parallel they had directly inoculated in the same plates e. Coli atcc 25922 as a negative quality control sample and that that after 18-24 hour incubation under co2, they had observed unexpected bacterial growth of red colonies on both lots. The customer said that they had discarded all their inventory of the concerned product and that patients' samples' were not tested on these two lots. The customer mentioned that the issue has been observed only on these two new product lots and that the expected negative results were obtained when testing previous lot number of the chromid? Strepto b agar reference 43461 with the same e. Coli atcc 25922 quality control sample. There is no indication or report from the customer to biom? Rieux that the discrepant results led to any adverse event related to any patient's state of health. The quality control sample results are not directly associated with any patient. An internal biom? Rieux investigation will be initiated.
Patient Sequence No: 1, Text Type: D, B5