Immulite 2000 Immuno Analyzer Class III

Company: DPC Cirrus, Inc.,
Date of Enforcement report: 2/7/01
Date of recall: 11/3/00 Class: III

PRODUCT:

Immulite 2000 Automated Immunoassay Analyzer Software
Versions 1.6 and 1.61. Recall No. Z-183-1.

REASON:

Software code is incorrect for manual dilutions in the Batch Tests by
Rack, which could cause incorrect calculation of results.

CODE: None.

MANUFACTURER: DPC Cirrus, Inc., Randolph, NJ

RECALLED BY:

Manufacturer, by facsimile and telephone on November 3, 2000 and November
6, 2000. Firm-initiated recall ongoing.

DISTRIBUTION:

Nationwide. There are 8 Government accounts. The product was shipped
internationally to Argentina, Australia, Austria, Brazil, Canada, Chile,
China, Colombia, Costa Rica, Cyprus, Czech Republic, Denmark, Finland,
France, Germany, Greece, India, Israel, Italy, Japan, Malaysia, Mexico,
Netherlands, Norway, Pakistan, Poland, Portugal, Russia, Saudi Arabia,
South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand,
Turkey, UK, Venezuela.

QUANTITY:

962.

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.

What’s New

FDA:  Exemptions, Variances, and Alternate Forms of Adverse Event Reporting for Medical Devices

Manufacturers, importers, and user facilities can request an exemption or variance from any or all of the medical device reporting requirements in 21 CFR Part 803.  Read more:  https://www.fda.gov/medical-devices/medical-device-reporting-mdr-how-report-medical-device-problems/exemptions-variances-and-alternate-forms-adverse-event-reporting-medical-devices

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