Day

June 9, 1998
CIBA Corning ACS 180 Plus Analyzers, used for numerous assays. Recall #Z-359-9. REASON A software error for Troponin I analysis caused erroneous results. CODE All ACS 180 Plus Analyzers with test definition AL software version. MANUFACTURER Chiron Diagnostics Corporation, Oberlin, Ohio. RECALLED BY Manufacturer, by letter/technical bulletin on June 9, 1998. Firm-initiated field correction complete....
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.Select Brand Antacid Peppermint Tablets, 75’s, Lot #7026, manufactured on March 1997, was placed “On Hold”, but was not physically labeled as such, nor did the computerized inventory system indicate this status. Accucal Calcium Antacid Peppermint Tablets, 150’s, Lot #7075 was marked “Rejected” as stored in the warehouse, but this status was not indicated in...
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Remote Webmeeting Assessments

SoftwareCPR can provide remote offsite assessments to support virtual offices.  Our consultants can utilize webmeeting tools to walk your teams through assessments such as:

  • 62304 compliance
  • Regulatory submission pre-review
  • Software risk analysis
  • Cybersecurity process and validation
  • Overall ISO 14971 risk management
  • Overview of software regulation with John Murray

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