An anomaly was discovered in inoqula software (b)(4) that had the potential to cause a mismatch between a specimen and plate.The mismatch could happen when the following conditions occur together: inoqula hardware is not operating, such as during a power outage.Pipette has already drawn a specimen waiting to be dispensed on a plate, and user selects the ¿reset¿ function from the system menu.An immediate update to the software was made and validated.All impacted customers were provided with the update and information on any mis-associated data in their system.This was done via a recall and an 806 form was submitted on 5 august, 2019.Field correction initiated on 26july, 2019.Capa# (b)(4) has been opened to further investigate this issue.
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It was reported that while using a bd kiestra¿ inoqula+¿ tla to process patient urine samples, the customer reported discrepancies in bacterial growth between the blood agar plates and the macconkey agar plates being used for culture after a power outage.Following the discovery of the discrepancy, instrument log files uncovered a number of pipetting errors.During the investigation into this issue, through automated log-file analysis numerous mis-associated plates/specimens were discovered.Customers are being informed about the events, including ids and accession ids that were mis-associated.No erroneous results reported.
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