CLASS II ONGOING Device recall · Reported 4 Dec 2019 · FDA Enforcement Report

Accessory kit, Alinity i containing Alinity ci Level Sensor recalled

Abbott Gmbh & Co. KG is recalling Accessory kit, Alinity i containing Alinity ci Level Sensor, Bulk Solution, distributed nationwide in the US. The recall was initiated on 16 Sep 2019 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesList Number 03R66 03, All Serial Numbers

Quantity recalled3,271 units

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-0544-2020
FDA event ID: 83847
Recalling firm: Abbott Gmbh & Co. KG, Wiesbaden
Classification: Class II
Status: Ongoing
Recall initiated: 16 Sep 2019
FDA classified: 22 Nov 2019
Reported: 4 Dec 2019
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Other Medical Devices

Timeline

16 Sep 2019	Recall initiated by company
22 Nov 2019	Classified by FDA	+67 days
4 Dec 2019	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

Potential reliability issue with the Alinity ci series Level Sensor, Bulk Solution. The development of environmental stress on the bulk solution level sensor can cause cracks.

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

Accessory kit, Alinity i containing Alinity ci Level Sensor, Bulk Solution

Where it was distributed

Nationwide distribution to AL, AR, AZ, CA, CO, FL, GA, ID, IL, IN, KS, LA, MA, ME, MI, MN, MO, MS, NC, NJ, NV, NY, OK, PR, SC, SD, TN, TX, UT, VA, WA, WI. International distribution to ALBANIA, ALGERIA, ARGENTINA, AUSTRALIA, AUSTRIA, BAHRAIN, BANGLADESH, BELGIUM, BOSNIA AND HERZEGOVINA, BOTSWANA, BRAZIL, BULGARIA, CANADA, CHILE, CHINA, COLOMBIA, CROATIA, CZECH REPUBLIC, DENMARK, 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, NAMIBIA, NETHERLANDS, NEW ZEALAND, NORWAY, OMAN, PAKISTAN, PHILIPPINES, POLAND, PORTUGAL, ROMANIA, RUSSIA, SAUDI ARABIA, SERBIA, SINGAPORE, SLOVAKIA, SLOVENIA, SOUTH AFRICA, SOUTH KOREA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, THAILAND, TRINIDAD & TOBAGO, TURKEY, UAE, UK, URUGUAY, VIETNAM.

Nationwide Alabama Arkansas Arizona California Colorado Florida Georgia Idaho Illinois Indiana Kansas Louisiana Massachusetts Maine Michigan Minnesota Missouri Mississippi North Carolina New Jersey

Questions about this recall

Why was it recalled?

Potential reliability issue with the Alinity ci series Level Sensor, Bulk Solution. The development of environmental stress on the bulk solution level sensor can cause cracks.

Which lots are affected?

List Number 03R66 03, All Serial Numbers

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.

Other products in this recall event

2 other products · FDA event 83847

Reported	Class	Recall	Company	Reason	Where
4 Dec 2019	CLASS II	Alinity ci Level Sensor, Bulk Solution recalled by Abbott Gmbh & Co. KG	Abbott Gmbh & Co. KG	Device Malfunction	Nationwide
4 Dec 2019	CLASS II	Accessory kit, Alinity c containing Alinity ci Level Sensor recalled	Abbott Gmbh & Co. KG	Device Malfunction	Nationwide

More recalls from Abbott Gmbh & Co. KG

All 19

Reported	Class	Recall	Company	Reason	Where
5 Aug 2020Device	CLASS II	Alinity ci series System Control Module (SCM) recalled	Abbott Gmbh & Co. KG	Device Malfunction	Nationwide
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

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