CLASS II Device recall · Reported 11 Mar 2020 · FDA Enforcement Report

Elecsys CA recalled by Roche Diagnostics Operations

Roche Diagnostics Operations is recalling Elecsys CA 19-9, distributed nationwide in the US. The recall was initiated on 7 Feb 2020 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot 416245 ***Updated 10/5/20*** 483123 ***Updated 8/5/22*** Additional released lots are subject to the same workaround: 46449, 50474,525510, and 568976

Quantity recalled684

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-1444-2020
FDA event ID: 84915
Recalling firm: Roche Diagnostics Operations, Indianapolis, IN
Classification: Class II
Status: Terminated
Recall initiated: 7 Feb 2020
FDA classified: 5 Mar 2020
Reported: 11 Mar 2020
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Potency & Assay
Device type: Patient Monitors

Timeline

7 Feb 2020	Recall initiated by company
5 Mar 2020	Classified by FDA	+27 days
11 Mar 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

The firm has received an increased number of complaints concerning non-reproducible elevated results ("high flyers") for one lot of Elecsys CA 19-9 reagent, which may affect clinical interpretation.

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

Elecsys CA 19-9, Cat. No. 07027028190 - Product Usage: the product is an immunoassay for monitoring and management of pancreatic cancer

Where it was distributed

US Nationwide distribution in the states of AL, AZ, CA, CO, FL, HI, IL, IN, KS, KY, MA, ME, MI, NC, NH, NJ, NY, TN, TX, WA and WI.

Nationwide Alabama Arizona California Colorado Florida Hawaii Illinois Indiana Kansas Kentucky Massachusetts Maine Michigan North Carolina New Hampshire New Jersey New York Tennessee Texas Washington

Questions about this recall

Is Elecsys CA 19-9 recalled?

Yes. Roche Diagnostics Operations recalled Elecsys CA 19-9 on 7 Feb 2020. The recall is Class II and its status is Terminated. Recall number Z-1444-2020.

Why was it recalled?

The firm has received an increased number of complaints concerning non-reproducible elevated results ("high flyers") for one lot of Elecsys CA 19-9 reagent, which may affect clinical interpretation.

Which lots are affected?

Lot 416245 ***Updated 10/5/20*** 483123 ***Updated 8/5/22*** Additional released lots are subject to the same workaround: 46449, 50474,525510, and 568976

Where was it sold?

US Nationwide distribution in the states of AL, AZ, CA, CO, FL, HI, IL, IN, KS, KY, MA, ME, MI, NC, NH, NJ, NY, TN, TX, WA and WI.

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.

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