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

Class II FDA enforcement event 88324. Recall start date: 12 Jul 2021. Status in the FDA record: Ongoing.

Reason for recall, in the words of FDA

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

Class II, in the words of FDA

a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote

Abbott Laboratories, Inc started this device recall on 12 Jul 2021. The firm address in the FDA record is in Irving, TX. FDA put the recall in Class II. FDA event 88324 has 1 product record. The first FDA enforcement report date is 18 Aug 2021. The record gives the status Ongoing.

FDA enforcement report The 1 product record

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on 1 Oct 2026. openFDA export of 28 Sep 2026.

Distribution

In the words of FDA.

Worldwide distribution. US nationwide, Australia, Bahrain, Belgium, Brazil, China, Colombia, Croatia, Egypt, Germany, Greece, Hong Kong, Hungary, Iran, Ireland, Israel, Italy, Jordan, Kuwait,…

Recalling firm

Abbott Laboratories, Inc, Irving, TX.

Recalling firm: The firm that the FDA record names for a recall.

FDA records how the recall started: Voluntary: Firm initiated.

Products

1 product record in the event.

FDA event 88324: product records
Recall number	Product	Quantity	Class	Status	Report date
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.	260 systems	Class II	Ongoing	18 Aug 2021

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Class II: The middle of the three FDA recall classes.

The event in context

Device events that started in 2021: 900
Share of these events in Class II: 89%
Product records in this event: 1Median of the firm: 1
Events of the firm on the register: 18

Other events of the firm

Other FDA enforcement events of Abbott Laboratories, Inc
Initiated	Product (first record)	Type	Class	Records
3 Feb 2022	Alinity s System software version2.8.0, REF LN 06P16-01, IVD, OEI: (01)00380740138479 The Alinity s System is intended f	Device	Class II	1
1 May 2019	ARCHITECT C System Mixer - Product Usage: The ARCHITECT Clinical Chemistry System is designed to perform automated chemi	Device	Class II	1
2 Jan 2019	ARCHITECT MAGNESIUM, (a) REF 7D70-21, (b) 7D70-31 The Magnesium assay is used for the quantitation of magnesium in human	Device	Class II	1
7 Sep 2018	APS Accelerator modular systems, 208-230 V-, 50/60 Hz, 1800 VA, IVD, RX, Class 2 Laser Product,	Device	Class II	1
28 Aug 2018	Abbott ARCHITECT cSystems ICT Module, REF 09D28-03. Product Usage: The ARCHITECT cSystems ICT (Integrated Chip Technolog	Device	Class II	1
18 Jul 2018	Abbott ARCHITECT Creatine Kinase, IVD, REF 7D63-21.	Device	Class II	2
17 Jul 2018	Abbott ARCHITECT c4000 Processing Module, List No. 02P24 - Product Usage: The Abbott ARCHITECT System is intended for In	Device	Class II	3
14 Jun 2018	CardioMEMS HF System Hospital and Patient Electronics Units: (a) Patient Electronics System, Model CM1100 (b) Hospital E	Device	Class II	1
16 May 2018	C3 is an in vitro diagnostic assay for the quantitative determination of C3 in human serum or plasma. Antibodies to C3 c	Device	Class II	9
8 Dec 2017	ARCHITECT c4000 Cuvette Segment, Part #02P75-01/02P24, a component to the ARCHITECT Clinical Chemistry system. There are	Device	Class II	3

Abbott Laboratories, Inc: all 18 events

Official channels

FDA enforcement report Z-2276-2021The FDA record of the first product of this event.
FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
FDA MedWatchThe FDA safety reporting program for drugs and medical devices.

Follow by RSS:Food, drug and device recallsFDA Class I recalls

Cite this page

Recall Register. FDA enforcement event 88324. https://recallregister.com/fda/ii/88324/. Source: openFDA enforcement reports. Data through 28 Sep 2026.

Sources

Source: openFDA device enforcement reports
Licence: CC0 1.0
Export date: 28 Sep 2026
Newest FDA report date on the register: 23 Sep 2026

FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.

Questions

Where was the product distributed?: The FDA record gives this distribution: Worldwide distribution. US nationwide, Australia, Bahrain, Belgium, Brazil, China, Colombia, Croatia, Egypt, Germany, Greece, Hong Kong, Hungary, Iran, Ireland, Israel, Italy, Jordan, Kuwait,…
What quantity of product is in FDA event 88324?: The FDA record gives this quantity: 260 systems
How did the recall start?: The FDA record says: Voluntary: Firm initiated
How many device recalls of 2021 have the same class?: 89% of the 900 device events that started in 2021 are in Class II.