CLASS II Device recall · Reported 5 Aug 2020 · FDA Enforcement Report

Alinity ci series System Control Module (SCM) recalled

Abbott Gmbh & Co. KG is recalling Alinity ci series System Control Module (SCM), distributed nationwide in the US. The recall was initiated on 19 Jun 2020 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesAll serial numbers of System Control Module

Quantity recalled3166

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2701-2020
FDA event ID: 85914
Recalling firm: Abbott Gmbh & Co. KG, Wiesbaden, N/A
Classification: Class II
Status: Terminated
Recall initiated: 19 Jun 2020
FDA classified: 24 Jul 2020
Reported: 5 Aug 2020
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Medical Software

Timeline

19 Jun 2020	Recall initiated by company
24 Jul 2020	Classified by FDA	+35 days
5 Aug 2020	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Quality Control results were not properly evaluated for QC failures.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

Alinity ci series System Control Module (SCM); LN 3R70-01 Alinity ci series software versions, 3.1.1 and below

Where it was distributed

Worldwide distribution - US Nationwide distribution and the countries of ALBANIA, ALGERIA, ARGENTINA, AUSTRALIA, AUSTRIA, BAHRAIN, BANGLADESH, BELGIUM, BERMUDA, BOSNIA AND HERZEGOVINA, BOTSWANA, BRAZIL, BULGARIA, BURKINA FASO, CANADA, CHILE, CHINA, COLOMBIA, COSTA RICA, CROATIA, CZECH REPUBLIC, DENMARK, EGYPT, ESTONIA, FINLAND, FRANCE, GERMANY, GREECE, GUATEMALA, HONG KONG, INDIA, INDONESIA, IRELAND, ISRAEL, ITALY, JAMAICA, JAPAN, JORDAN, KAZAKHSTAN, KENYA, KUWAIT, LATVIA, LEBANON, LITHUANIA, MADAGASCAR, MALAYSIA, MEXICO, MOROCCO, NAMIBIA, NETHERLANDS, NEW CALEDONIA, NEW ZEALAND, NORWAY, OMAN PAKISTAN, PERU, PHILIPPINES, POLAND, PORTUGAL, PUERTO RICO, ROMANIA, RUSSIA, SAUDI ARABIA, SERBIA, SINGAPORE, SLOVAKIA, SLOVENIA, SOUTH AFRICA, SOUTH KOREA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, THAILAND, TRINIDAD & TOBAGO, TURKEY, UAE, UK, UKRAINE, URUGUAY, VIETNAM.

Nationwide Puerto Rico

Questions about this recall

Why was it recalled?

Quality Control results were not properly evaluated for QC failures.

Which lots are affected?

All serial numbers of System Control Module

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Abbott Gmbh & Co. KG

All 19

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24 Jun 2020Device	CLASS II	Alinity C, Processing Module recalled by Abbott Gmbh & Co. KG	Abbott Gmbh & Co. KG	Potency & Assay	25 states
3 Jun 2020Device	CLASS II	Architect iGentamicin Reagent Kit recalled by Abbott Gmbh & Co. KG	Abbott Gmbh & Co. KG	Potency & Assay	Nationwide
29 Apr 2020Device	CLASS II	Architect Havab G Reagent Kit recalled by Abbott Gmbh & Co. KG	Abbott Gmbh & Co. KG	Hepatitis A	Nationwide
1 Apr 2020Device	CLASS II	LN 3R70 recalled by Abbott Gmbh & Co. KG	Abbott Gmbh & Co. KG	Device Malfunction	Nationwide
4 Dec 2019Device	CLASS II	Accessory kit, Alinity c containing Alinity ci Level Sensor recalled	Abbott Gmbh & Co. KG	Device Malfunction	Nationwide

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