Z-1909-2013 Class II Terminated
FDA device recall Z-1909-2013 was initiated by Biomerieux Inc on Jun 14, 2013 and is designated Class II. Reason for recall: A product issue has been identified for customers using software version 6.01 and are interfaced with a Laboratory Information System (LIS). During the update of software from version 5.xx to 6.01… The recall status is terminated (terminated Jun 1, 2015). Affected quantity: 12,384 total kits.
Recall Details
- Product Type
- Devices
- Report Date
- Aug 14, 2013
- Initiation Date
- Jun 14, 2013
- Termination Date
- Jun 1, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 12,384 total kits
Product Description
Reason for Recall
Distribution Pattern
Worldwide distribution: US (nationwide) and countries of: Argentina, Australia, Austria, Bahrain, Belarus, Benelux, Brazil, Bulgaria, Canada, Chile China, Costa Rica, Croatia, Czech Republic, Dominican Republic, Dutch Antilles, Ecuador, Egypt, France, Germany, Hong Kong, Hungary, India, Indonesia, Israel, Italy, Japan, Kazakhstan, Korea, Kuwait, Libya, Lithuania, Macedonia, Malaysia, Malta, Mexico, Morocco, Myanmar, Netherlands, Nicaragua, Nigeria, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Romania, Russia, Serbia, Singapore, Slovenia, Spain, Sweden, Switzerland, South Africa, Thailand, Tunisia, United Arab Emirates, United Kingdom, Uruguay, and Vietnam.
Code Information
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1909-2013
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026