CLASS II Device recall · Reported 1 Apr 2020 · FDA Enforcement Report

LN 3R70 recalled by Abbott Gmbh & Co. KG

Abbott Gmbh & Co. KG is recalling LN 3R70-01, distributed nationwide in the US. The recall was initiated on 24 Jan 2020 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLN 3R70-01; software version 2.6.2 and earlier.

Quantity recalled2676 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-1580-2020
FDA event ID: 84831
Recalling firm: Abbott Gmbh & Co. KG, Wiesbaden, N/A
Classification: Class II
Status: Terminated
Recall initiated: 24 Jan 2020
FDA classified: 26 Mar 2020
Reported: 1 Apr 2020
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Medical Software

Timeline

24 Jan 2020	Recall initiated by company
26 Mar 2020	Classified by FDA	+62 days
1 Apr 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

Abbott has identified potential performance issues for the Alinity ci -series Software version 2.6.2 and earlier.

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

LN 3R70-01; software version 2.6.2 and earlier. The software is used with the Alinity i (LN 03R65-01) processing module and the Alinity c (LN 03R67-01) processing module.

Where it was distributed

Worldwide distribution - US Nationwide distribution in the states of AL, AR, AZ, CA, CO, FL, GA, ID, IL, LA, MA, MD, ME, MI, MN, MC, MS, NC, NJ, NY, OK, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV and countries of Albania, Argentina, Australia, Austria, Bahrain, Bangledesh, Belgium, Bermuda, Bosnia, Botswana, Brazil, Bulgaria, Burkina Faso, Canada, Chile, China, Columbia, Costa Rica, 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 Caledonia, New Zealand, Norway, Oman, Pakistan, Peru, Philippines, Poland, Portugal, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Trinidad and Tobago Turkey, UEA, UK, Ukraine, Uruguay, Vietnam.

Nationwide Alabama Arkansas Arizona California Colorado Florida Georgia Idaho Illinois Louisiana Massachusetts Maryland Maine Michigan Minnesota Mississippi North Carolina New Jersey New York Oklahoma

Questions about this recall

Is LN 3R70-01 recalled?

Yes. Abbott Gmbh & Co. KG recalled LN 3R70-01 on 24 Jan 2020. The recall is Class II and its status is Terminated. Recall number Z-1580-2020.

Why was it recalled?

Abbott has identified potential performance issues for the Alinity ci -series Software version 2.6.2 and earlier.

Which lots are affected?

LN 3R70-01; software version 2.6.2 and earlier.

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 21 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

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
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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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