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Catalog Number 292396 |
Device Problem
Incorrect, Inadequate or Imprecise Result or Readings (1535)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/20/2022 |
Event Type
malfunction
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Event Description
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It was reported that 197 bd bbl¿ trypticase¿ soy agar, heavy fill sterile plates from lot 1214894, and 1 plate from lot 1260098 had pre-existing, embedded colonies in their agar.There was no report of user or patient impact.The following information was provided by the initial reporter: "customer reporting embedded particles in product 292396 - plate sterile tsa heavy fill." "customer reports plates are unusable due to existing embedded colonies in the agar."colonies" are not visualized until after the incubation periods of 3-5 days at 20-25 degrees celsius and 2-3 days at 30-35 degrees celsius.This impacts the facility environmental monitoring program and corresponding production planning." "197 plates from lot 1214894; 1 plate from lot 1260098.".
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Manufacturer Narrative
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There were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 1214894, medical device expiration date: 2022-01-14,and device manufacture date: 2021-08-21; medical device lot #: 1260098, medical device expiration date: 2022-03-03,and device manufacture date: 2021-10-03.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
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Manufacturer Narrative
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Correction: after further review, it was found that this is a luo kit (laboratory use only) and is not a registered medical device in the us.This product is also not an accessory device to the bd max instrument.Therefore, this complaint will be cancelled.
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Event Description
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It was reported that 197 bd bbl¿ trypticase¿ soy agar, heavy fill sterile plates from lot 1214894, and 1 plate from lot 1260098 had pre-existing, embedded colonies in their agar.There was no report of user or patient impact.The following information was provided by the initial reporter: "customer reporting embedded particles in product 292396 - plate sterile tsa heavy fill." "customer reports plates are unusable due to existing embedded colonies in the agar."colonies" are not visualized until after the incubation periods of 3-5 days at 20-25 degrees celsius and 2-3 days at 30-35 degrees celsius.This impacts the facility environmental monitoring program and corresponding production planning." "197 plates from lot 1214894; 1 plate from lot 1260098".
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Search Alerts/Recalls
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