Z-1486-2018 Class II Terminated
FDA device recall Z-1486-2018 was initiated by Siemens Healthcare Diagnostics, Inc on Feb 21, 2018 and is designated Class II. Reason for recall: Upon dilution, some patient samples may exhibit over-recovery outside the representative data provided in the assay instructions for use. The recall status is terminated (terminated May 16, 2019). Affected quantity: SMN 10310443 (1-pack/100 tests) - 13257 kits; SMN 10315696 (5-pack/500 tests) - 9930 kits.
Recall Details
- Product Type
- Devices
- Report Date
- May 2, 2018
- Initiation Date
- Feb 21, 2018
- Termination Date
- May 16, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- SMN 10310443 (1-pack/100 tests) - 13257 kits; SMN 10315696 (5-pack/500 tests) - 9930 kits
Product Description
Reason for Recall
Distribution Pattern
US Nationwide, and the following countries: Albania, Angola, Argentina, Armenia, Australia, Austria, Bahrain, Bangladesh, Belgium, Bosnia Herzegovina, Brazil, Bulgaria, Cambodia, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Ecuador, Egypt, Estonia, Finland, France, Georgia, Germany, Greece, Hong Kong, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Latvia, Lithuania, Luxembourg, Macedonia, Malaysia, Malta, Mexico, Morocco, Myamar, Nepal, Netherlands, New Zealand, Nicaragua, Norway, Pakistan, Paraguay, Peru, Philippines, Poland, Portugal, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sri Lanka, Sweden, Switzerland, Taiwan,Thailand, Turkey, United Arab Emirates, Ukraine, United Kingdom, Uruguay, Uzbekistan,Vatican City, 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-1486-2018
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026