Use cautionMedical device recall · FDA · Published July 12, 2021
Abbott Alinity s System Recall: Liquid Waste Spray Hazard
Abbott recalls Alinity s System REF 06P16-01 due to liquid waste pressure buildup that may spray users. Affected units have serial numbers AS1001 to AS1330.
“Abbott Alinity s System Recall: Liquid Waste Spray Hazard.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/62212-abbott-alinity-s-system-recall-liquid-waste-spray-hazard. Based on FDA recall #Z-2276-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2276-2021%22&limit=1).
The FDA announced on July 12, 2021, that Abbott Laboratories, Inc. is recalling the Alinity s System (REF 06P16-01) due to a design defect that allows liquid waste pressure to build up and potentially spray users or operators.
How to tell if you have it
Brand: Abbott
Product: Alinity s System
Reference Number: REF 06P16-01
Model Number: LN 06P16-01
Serial Numbers: AS1001 through AS1330
The hazard
A design defect in the hardware and software allows liquid waste pressure to build up and potentially spray users or operators, according to the FDA.
Context
GovInfoNow's records show Abbott Laboratories, Inc. has 11 other recalls on record since September 29, 2017. Other recent recalls of similar products include Boston Scientific Intera 3000 Hepatic Artery Pump Recall (May 11, 2026), Arrow Medical Drainage Kits Recall (April 21, 2026) and Arrow HemoDialysis Kit Recall (April 21, 2026).
How to tell if you have this one
Check for serial numbers AS1001 through AS1330 on the Alinity s System REF 06P16-01. The device is used in blood donor screening, plasma and plasmapheresis testing at hospitals and labs.
Brand
Abbott
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check for Serial Numbers
Look for serial numbers AS1001 through AS1330 on the Alinity s System REF 06P16-01.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
Nationwide
Not listed
FDA distribution: “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,…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA published this recall 37 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-2276-2021 (July 12, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2276-2021 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.