CLASS III Device recall · Reported 21 Oct 2020 · FDA Enforcement Report

Albumin Gen.2 recalled by Roche Diagnostics Operations

Roche Diagnostics Operations is recalling Albumin Gen.2, distributed nationwide in the US. The recall was initiated on 27 Aug 2020 and the FDA has classified it as Class III.

Check your package

Lot, batch or date codeslots 43031001, 43718901

Quantity recalled11963

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-0104-2021
FDA event ID: 86406
Recalling firm: Roche Diagnostics Operations, Indianapolis, IN
Classification: Class III
Status: Terminated
Recall initiated: 27 Aug 2020
FDA classified: 13 Oct 2020
Reported: 21 Oct 2020
Type: Voluntary: Firm initiated
Customers notified by: N/A
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

27 Aug 2020	Recall initiated by company
13 Oct 2020	Classified by FDA	+47 days
21 Oct 2020	Published in enforcement report	+8 days

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

Reason for recall

Roche has confirmed customer complaints of low quality (QC) recovery and invalid calibrations for the identified products. A discoloration (yellow color) was observed and is the result of cross contamination between the R1 and R3 reagents.

Product as listed by the FDA

Albumin Gen.2, Catalog 05166861190

Where it was distributed

Domestic distribution nationwide.

Nationwide

Questions about this recall

Is Albumin Gen.2 recalled?

Yes. Roche Diagnostics Operations recalled Albumin Gen.2 on 27 Aug 2020. The recall is Class III and its status is Terminated. Recall number Z-0104-2021.

Why was it recalled?

Which lots are affected?

lots 43031001, 43718901

Where was it sold?

Domestic distribution nationwide.

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 III mean?

Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.

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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