FDAFDA · Food and drugs·Recall number Z-0884-2022
Alinity m HBV AMP Kit (US and CE)
Published April 13, 2022 · Recall initiated: March 4, 2022
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
There is a potential for misquantitation high results for negative samples.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Abbott Molecular, Inc.
- Distributor
- 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
- Lot
- List Numbers: 1) 08N47-095 (US); Lots: 519756, 523799, and 524361, Updated to add: 381583, 529391, 529687, 530273, 531598; 2) 08N47-090 (CE); Lots: 519755, 520957, 522137, 523798, and 524059, Updated to add: 380963, 380979, 381021, 529378, 529686, 530272, 531189, 531596
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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