Field correction initiated on 26 july, 2019.Capa# (b)(4) has been opened to further investigate this issue.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.
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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 macconkry agar plates being used for culture after a power outage.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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