Model Number 246004 |
Device Problem
Expiration Date Error (2528)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/17/2021 |
Event Type
malfunction
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Manufacturer Narrative
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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 153 bd phoenix¿ ast indicator solutions incorrect label information was observed by the laboratory personnel.There was no report of patient impact.The following information was provided by the initial reporter: "the expiration date shown on vial label is 30 apr 2020 while the expiration date shown on box label and coc is 30 apr 2022.End-users will not accept this issue.".
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Manufacturer Narrative
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H6: investigation summary this complaint is for the incorrect expiration date on the foil pouch of phoenix ast indicator (246004) batch 1105781.The customer did return multiple photos which showed the pouch with a date of 04-30-2020 when the correct expiration date is 04-30-2022.The photos also showed the carton which displayed the correct expiration date of 04-30-2022.To investigate further the expiration date was verified along with manufacture date.It was determined that the expiration of 04-30-2022 was the correct date of expiration and that the product was useable.Based on the photos provided this complaint is confirmed.A review of quality notifications revealed one quality notification generated on the complaint batch, qn (b)(4).A review of complaints was performed and there were fifteen additional complaints filed for this batch not all for the same defect.A complaint trend was identified for this defect.Based on the severity and rate, a corrective and preventive action (capa) investigation was not initiated.
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Event Description
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It was reported that while using 153 bd phoenix¿ ast indicator solutions incorrect label information was observed by the laboratory personnel.There was no report of patient impact.The following information was provided by the initial reporter: "the expiration date shown on vial label is 30 apr 2020 while the expiration date shown on box label and coc is (b)(6) 2022.End-users will not accept this issue.".
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Search Alerts/Recalls
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