Alinity m System, Part No. 08N53-002
Reported: January 12, 2022 Initiated: December 6, 2021 #Z-0460-2022
Product Description
Alinity m System, Part No. 08N53-002
Reason for Recall
There is a potential for abnormal (non-sigmoidal) amplification curves.
Details
- Recalling Firm
- Abbott Molecular, Inc.
- Units Affected
- 742 devices
- Distribution
- Worldwide distribution - US Nationwide and the countries of Australia, Austria, Belgium, Brazil, Cambodia, Canada, Chile, Colombia, Czech Republic, Egypt, El Salvador, Estonia, Finland, France, Germany, Hong Kong, Ireland, Israel, Italy, Japan, Malawi, Malaysia, Mexico, Montenegro, Morocco, Mozambique, Netherlands, New Zealand, Norway, Pakistan, Poland, Portugal, Romania, Russia, Saudi Arabia, Singapore, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Uganda, United Kingdom, and Vietnam.
- Location
- Des Plaines, IL
Frequently Asked Questions
What product was recalled? ▼
Alinity m System, Part No. 08N53-002. Recalled by Abbott Molecular, Inc.. Units affected: 742 devices.
Why was this product recalled? ▼
There is a potential for abnormal (non-sigmoidal) amplification curves.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on January 12, 2022. Severity: Moderate. Recall number: Z-0460-2022.
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