CLASS II Device recall · Reported 24 Jun 2020 · FDA Enforcement Report

Alinity C, Processing Module recalled by Abbott Gmbh & Co. KG

Abbott Gmbh & Co. KG is recalling Alinity C, Processing Module, distributed in 25 states. The recall was initiated on 12 May 2020 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesList Number: 03R67-01: All serial numbers

Quantity recalled421 serial numbers

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-2401-2020
FDA event ID: 85686
Recalling firm: Abbott Gmbh & Co. KG, Wiesbaden
Classification: Class II
Status: Terminated
Recall initiated: 12 May 2020
FDA classified: 18 Jun 2020
Reported: 24 Jun 2020
Type: Voluntary: Firm initiated
Customers notified by: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Reason category: Potency & Assay
Device type: Test Kits & Diagnostics

Timeline

12 May 2020	Recall initiated by company
18 Jun 2020	Classified by FDA	+37 days
24 Jun 2020	Published in enforcement report	+6 days

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

Reason for recall

There is a potential to generate incorrect patient results for the following assays: Alkaline Phosphatase, Amylase, Creatine Kinase, and Gamma Glutamyl Transferase.

Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.

Product as listed by the FDA

Alinity C, Processing Module. Chemistry analyzer for in-vitro diagnostics.

Where it was distributed

U.S. States: AR, CA, CO, FL, GA, KS, KY, LA, MD, MI, MN, MO, MS, NC, NJ, NY, OK, SC, SD, TN, TX, UT, VA, WI, PR Worldwide distribution: ALBANIA, ALGERIA, ARGENTINA, AUSTRALIA, AUSTRIA, BANGLADESH, BELGIUM, BERMUDA, BRAZIL, CANADA, CHILE, COLOMBIA, CROATIA, CZECH REPUBLIC, DENMARK, FINLAND, FRANCE, GERMANY, GREECE, HONG KONG, INDIA, INDONESIA, ISRAEL, ITALY, JAMAICA, JORDAN, KENYA, MALAYSAI, MEXICO, NEW CALEDONIA, NORWAY, OMAN, PAKISTAN, PHILIPPINES, POLAND, PORTUGAL, ROMANIA, SAUDIA ARABIA, SERBIA, SINGAPORE, SPAIN, SWEDEN, SWITZERLAND, THAILAND, TRINIDAD & TOBAGO, TURKEY, UAE, UK, URUGUAY, and VIETNAM.

Arkansas California Colorado Florida Georgia Kansas Kentucky Louisiana Maryland Michigan Minnesota Missouri Mississippi North Carolina New Jersey New York Oklahoma Puerto Rico South Carolina South Dakota

Questions about this recall

Why was it recalled?

There is a potential to generate incorrect patient results for the following assays: Alkaline Phosphatase, Amylase, Creatine Kinase, and Gamma Glutamyl Transferase.

Which lots are affected?

List Number: 03R67-01: 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.

More recalls from Abbott Gmbh & Co. KG

All 19

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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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