Alinity m HBV AMP Kit (US and CE)
Reported: April 13, 2022 Initiated: March 4, 2022 #Z-0884-2022
Product Description
Alinity m HBV AMP Kit (US and CE)
Reason for Recall
There is a potential for misquantitation high results for negative samples.
Details
- Recalling Firm
- Abbott Molecular, Inc.
- Units Affected
- 4966 kits, updated 101/17/2023
- Distribution
- US consignees - AZ, CA, IL, IN, MA, MI, MO, NH, NJ, NY, OH, SD, TX, and VA OUS consignees - Australia, Austria, Belgium, Brazil, Canada, Columbia, Czech Republic, El Salvador, Estonia, France, Germany, Israel, Italy, Japan, Latvia, Malaysia, Netherlands, New Zealand, Norway, Pakistan, Poland, Portugal, Romania, Russia, Saudi Arabia, Singapore, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, United Kingdom, and Vietnam
- Location
- Des Plaines, IL
Frequently Asked Questions
What product was recalled? ▼
Alinity m HBV AMP Kit (US and CE). Recalled by Abbott Molecular, Inc.. Units affected: 4966 kits, updated 101/17/2023.
Why was this product recalled? ▼
There is a potential for misquantitation high results for negative samples.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 13, 2022. Severity: Moderate. Recall number: Z-0884-2022.
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