CLASS II Device recall · Reported 24 Oct 2018 · FDA Enforcement Report

Atellica Sample Handler Prime (SMN 11069001) recalled

Siemens Healthcare Diagnostics is recalling Atellica Sample Handler Prime (SMN 11069001), distributed nationwide in the US. The recall was initiated on 29 Jun 2018 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesSoftware (SW) version 1.13 and lower

Quantity recalled107

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-0189-2019
FDA event ID: 80774
Recalling firm: Siemens Healthcare Diagnostics, Tarrytown, NY
Classification: Class II
Status: Terminated
Recall initiated: 29 Jun 2018
FDA classified: 18 Oct 2018
Reported: 24 Oct 2018
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Potency & Assay
Device type: Test Kits & Diagnostics

Timeline

29 Jun 2018	Recall initiated by company
18 Oct 2018	Classified by FDA	+111 days
24 Oct 2018	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

Atellica Solution system software (SW) version 1.13 and lower, five (5) behavioral issues were identified: 1. Reagent Lock may not work as intended with Primary Reagent ReadyPacks¿ and Ancillary Packs when more than one (1) lot of specific Reagent kits are loaded on the analyzer at the same time. 2. Sample barcodes may be incorrectly read 3. The Atellica IM 1300 Analyzer and Atellica IM 1600 Analyzer may not run CEA dilutions at 50x and 100x. The Analyzer may post a Sample Integrity Error when 50x or 100x dilutions are ordered for Carcinoembryonic Antigen (CEA). Dilution factors lower than 50x and neat samples are not affected by this behavior. 4. The Atellica CH 930 Analyzer may continue to display the default reporting units after the reporting units have been changed. 5. The Atellica CH 930 Analyzer may not display results for sample if certain assays are configured to auto-dilute results above or below the assay measuring interval.

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

Atellica Sample Handler Prime (SMN 11069001). The Atellica" Solution is a multi-component system for in vitro diagnostic testing of clinical specimens.

Where it was distributed

Nationwide Foreign: Australia Austria Belgium Brazil Canada Croatia Czech Republic Denmark France Germany Greece Italy Japan Malaysia Mexico Netherlands Norway Poland Republic Korea Singapore Spain Sweden Switzerland U.A.E. United Kingdom

Nationwide

Questions about this recall

Why was it recalled?

Which lots are affected?

Software (SW) version 1.13 and lower

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

5 other products · FDA event 80774

Reported	Class	Recall	Company	Reason	Where
24 Oct 2018	CLASS II	Atellica IM 1600 Analyzer (SMN 11066000) recalled	Siemens Healthcare Diagnostics	Potency & Assay	Nationwide
24 Oct 2018	CLASS II	Atellica Sample Handler Additional (SMN 11069004) recalled	Siemens Healthcare Diagnostics	Potency & Assay	Nationwide
24 Oct 2018	CLASS II	Atellica Sample Handler Connect (SMN 11069018) recalled	Siemens Healthcare Diagnostics	Potency & Assay	Nationwide
24 Oct 2018	CLASS II	Atellica CH 930 Analyzer (SMN 11067000) . The Atellica" recalled	Siemens Healthcare Diagnostics	Potency & Assay	Nationwide
24 Oct 2018	CLASS II	Atellica IM 1300 Analyzer (SMN 11066001) recalled	Siemens Healthcare Diagnostics	Potency & Assay	Nationwide

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