Device recall: Alinity ci-series System Control Module, REF: 03R70-01

Class II FDA enforcement event 93483. Recall start date: 30 May 2023. Status in the FDA record: Ongoing.

Reason for recall, in the words of FDA

There are potential performance issues found in the Alinity ci-series System software versions 3.4.0 and lower, including: 1) SCC Reagent load error during daily maintenance; 2) Sample Laboratory Report error; 3) Customer requests mechanism to prevent user error when creating new lots of value assigned Calibrators; 4) Error in processing tests after CCCintController encountered an error with the…

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 started this device recall on 30 May 2023. The firm address in the FDA record is in Irving, TX. FDA put the recall in Class II. FDA event 93483 has 1 product record. The first FDA enforcement report date is 3 Jan 2024. 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.

US: AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV OUS:…

Recalling firm

Abbott Laboratories, 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 93483: product records
Recall number	Product	Quantity	Class	Status	Report date
Z-0613-2024	Alinity ci-series System Control Module, REF: 03R70-01	8,424	Class II	Ongoing	3 Jan 2024

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 2023: 917
Share of these events in Class II: 88%
Product records in this event: 1Median of the firm: 1
Events of the firm on the register: 46

Other events of the firm

Other FDA enforcement events of Abbott Laboratories
Initiated	Product (first record)	Type	Class	Records
13 Nov 2025	Alinity ci-series System Control Module (SCM), REF: 03R70-01, 03R70-20	Device	Class II	1
18 Sep 2025	Brand Name: Alinity hq Analyzer Product Name: Alinity hq Analyzer Model/Catalog Number: 09P68-01 Software Version: 5.0 t	Device	Class II	1
18 Mar 2025	Brand Name: CELL-DYN Ruby Product Name: CELL-DYN Ruby Model/Catalog Number: 08H67-01 Software Version: All software vers	Device	Class II	5
14 Jun 2024	Alinity hq Analyzer, REF: 09P68-01	Device	Class II	1
21 Feb 2024	ARCHITECT STAT Myoglobin Reagent Kit, LN 2K43-25 and 2K43-20.	Device	Class II	1
31 Oct 2023	Similac Probiotic Tri-Blend - 0.017oz (0.50g) packaged in foil packets. 50 foil packets per carton - 3 cartons per case.	Food	Class II	1
19 Oct 2023	Abbott CELL-DYN Ruby, Model CD-Ruby, List number 08H67-01, and Abbott CELL-DYN Sapphire, Model CD Sapphire, list number	Device	Class II	1
19 Oct 2023	Alinity i Processing Module REF 03R65-01 The Alinity i Processing Module is a fully automated immunoassay analyzer allow	Device	Class II	3
28 Mar 2023	Zone Perfect Fudge Graham bar 50g bars packaged in foil wrapped- 12 bars individually wrapped per cardboard carton	Food	Class II	1
24 Nov 2022	Alinity Reaction Vessels, REF: 06P1401, for use with Alinity i Systems; ARCHITECT Reaction Vessels	Device	Class III	1

Abbott Laboratories: all 46 events

Official channels

FDA enforcement report Z-0613-2024The 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.

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Cite this page

Recall Register. FDA enforcement event 93483. https://recallregister.com/fda/ii/93483/. 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: US: AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV OUS:…
What quantity of product is in FDA event 93483?: The FDA record gives this quantity: 8,424
How did the recall start?: The FDA record says: Voluntary: Firm initiated
How many device recalls of 2023 have the same class?: 88% of the 917 device events that started in 2023 are in Class II.