FDAFDA · Food and drugs·Recall number Z-2276-2021
Alinity s System REF 06P16-01. An automated immunoassay analyzer for In Vitro diagnostic use in blood donor screening, plasma and plasmapheresis screening, and organ donor centers, hospitals, and reference laboratories.
Published August 18, 2021 · Recall initiated: July 12, 2021
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
A design defect (hardware and software) allows liquid waste pressure to build up and potentially spray users/operators.
What to do
Voluntary: Firm initiated · Visit
Recall details
- Manufacturer
- Abbott Laboratories, Inc
- Distributor
- Worldwide distribution. US nationwide, Australia, Bahrain, Belgium, Brazil, China, Colombia, Croatia, Egypt, Germany, Greece, Hong Kong, Hungary, Iran, Ireland, Israel, Italy, Jordan, Kuwait, Mexico, Netherlands, Pakistan, Poland, Portugal, Saudi Arabia, Serbia, Slovenia, South Africa, Spain, Tanzania, United Arab Emirates, United Kingdom, Ukraine and Zimbabwe.
- Lot
- Model Number: LN 06P16-01 Serial numbers AS1001 through AS1330
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.