Z-1059-2022 Class II Ongoing
FDA device recall Z-1059-2022 was initiated by bioMerieux, Inc. on Mar 29, 2022 and is designated Class II. Reason for recall: Software issue where results sent to the LIS via HL7 format for antibiotic screen tests and synergy tests do not include the user-corrected or AES-corrected interpretation. This can potentially lead… The recall status is ongoing. Affected quantity: 21,757 systems.
Recall Details
- Product Type
- Devices
- Report Date
- May 18, 2022
- Initiation Date
- Mar 29, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 21,757 systems
Product Description
Reason for Recall
Distribution Pattern
U.S. distribution of the FSCA to NC. OUS distribution of the FSCA to subsidiaries in Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Czech Republic, Egypt, Finland, France, Germany, Greece, Hungary, India, Italy, Japan, Mexico, Netherlands, Norway, Philippines, Poland, Portugal, Russia, Serbia, Sweden, Singapore, South Africa, South Korea, Spain, Switzerland, Thailand, Turkey, and United Kingdom.
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-1059-2022
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026