Z-2276-2021Class II

Alinity s System REF 06P16-01. An automated immunoassay analyzer for In Vitro diagnostic use in blood donor...

Name: Z-2276-2021 Alinity s System REF 06P16-01. An automated immunoassay analyzer for In Vitro diagnostic use in blood donor...
Creator: Abbott Laboratories, Inc
Published: 2021-07-12
License: https://open.fda.gov/license/

Abbott Medical / initiated 2021-07-12 / Open, Classified / root cause: software

FDA source

Abbott Laboratories, Inc began a recall of Alinity s System REF 06P16-01. An automated immunoassay analyzer for In Vitro diagnostic use in blood donor screening, plasma and plasmapheresis screening, and... on 2021-07-12. FDA classified it as Class II and gives the reason as "A design defect (hardware and software) allows liquid waste pressure to build up and potentially spray users/operators". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-2276-2021
Classification: Class II
Status: Open, Classified
Initiated: 2021-07-12
Posted: 2021-08-12
Recalling firm: Abbott Medical
Product: 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.
Product code: MZA Test, Equipment, Automated Bloodborne Pathogen
Reason for recall: A design defect (hardware and software) allows liquid waste pressure to build up and potentially spray users/operators.
Root cause tag: software
FDA root cause: Software design
Action: On 07/12/2021, the firm started hand-delivering an "Product Correction Urgent-Immediate Action Required" Notification to customers informing them that the Recalling Firm has identified an issue with pressure build up in the external waste tubing of the liquid waste assembly system if obstructed leading to a potential for biohazardous exposure and/or operator injury (contact with liquid waste). Customers are instructed to follow the below instruction until the Recalling Firm can upgrade the analyzers with a future system software version and a hardware component: 1. As stated in Section 8, Hazards, follow all product labeling and safety instructions in the laboratory. Always wear personal protective equipment (PPE) when operating the analyzer system, other laboratory instrumentation and equipment, and when using chemicals. 2. Adhere to the instructions listed in the Operations Manual, Section 10, to resolve message codes pertaining to waste overflow and contact Customer Service to resolve issues related to hardware failure. 3. Use caution when handling the Alinity s System external waste tubing. Avoid any configuration that could impact the free flow of the external waste and cause pressure buildup within the external waste tubing. A future software update and associated hardware upgrade will be implemented to enable external liquid waste tubing pressure monitoring and the display of the expected message code 5101 Liquid waste high pressure detected. 4. If customers have forwarded the product listed above to other laboratories, please inform them of this Product Correction and provide to them a copy of this letter. 5. Complete and return the Customer Reply form. 6. Retain this letter for their laboratory records. If customers or any of the health care providers have questions regarding this information, U.S. Customers contact Customer Service at 1-877-4ABBOTT (available 24 hours a day, 7 days a week). Customers outside the U.S., please contact your local area Cust
Quantity in commerce: 260 systems
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, Portugal, Saudi Arabia, Serbia, Slovenia, South Africa, Spain, Tanzania, United Arab Emirates, United Kingdom, Ukraine and Zimbabwe.
Product codes and lots: Model Number: LN 06P16-01 Serial numbers AS1001 through AS1330

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2276-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2276-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-08-18	2021-08-12

Product code MZA

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)