Abbott Laboratories, Inc: 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.

Recall number

Z-2276-2021

Recalling firm

Abbott Laboratories, Inc

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.

Status

Open, Classified

Initiated

2021-07-12

Posted

not on file

Terminated

not on file

Reason

A design defect (hardware and software) allows liquid waste pressure to build up and potentially spray users/operators.

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

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.

Lot, serial or model codes

Model Number: LN 06P16-01 Serial numbers AS1001 through AS1330

510(k) numbers

not on file

PMA numbers

not on file

Product code

MZA

Firm FEI

1628664

Firm city

Irving

Firm state

TX

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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