Model Number 442960 |
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 07/07/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Medical device expiration date: unknown.Device manufacture date: unknown.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.
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Event Description
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It was reported that while using bd max¿ enteric parasite panel 18 false positive results were obtained by the laboratory personnel.Repeat tests were used to confirm the results as false positives.There was no indication that results were reported out and there was no report of patient impact.The following information was provided by the initial reporter: " it was reported that multiple false positive results for cryptosporidium while using cat 442960.".
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Event Description
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It was reported that while using bd max¿ enteric parasite panel 18 false positive results were obtained by the laboratory personnel.Repeat tests were used to confirm the results as false positives.There was no indication that results were reported out and there was no report of patient impact.The following information was provided by the initial reporter: " it was reported that multiple false positive results for cryptosporidium while using cat 442960.".
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Manufacturer Narrative
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This mdr should be considered canceled.This was determined to be an instrument issue, not a reagent issue.The instrument malfunction was reported under mfr report number: 1119779-2021-01473.
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Search Alerts/Recalls
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