Boehringer917 chemistry analyzer Class II 32 units

Boehringer Mannheim/Hitachi 917 Disk System, a clinical chemistryanalyzer system. Recall #Z-1040-9.


The barcode reader can read the wrong sample barcode, mismatch
the test results, and report them under the wrong sample.


All versions of the disk system software with an updated barcode
reader. This includes the system with Serial No. 9715-05 and all
Serial Numbers greater than 9805-10.


Hitachi Ltd., Instrument Division, Ibari-ken, Japan.


Roche Diagnostics Corporation, Indianapolis, Indiana, by letter
dated June 8, 1999. Firm-initiated field correction ongoing.


Arizona, California, Connecticut, Delaware, Illinois, Indiana,
Iowa, Maryland, Massachusetts, Michigan, New Jersey, Ohio,
Pennsylvania, Rhode Island, South Carolina, Washington, West
Virginia, Wisconsin, Canada.


32 analyzers were distributed in North America.

About the author

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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