CLASS II Device recall · Reported 2 Jan 2013 · FDA Enforcement Report

Cobas AmpliPrep Instrument (Cap) with Amplilink (AL) recalled

Roche Molecular Systems is recalling Cobas AmpliPrep Instrument (Cap) with Amplilink (AL), distributed in California, Georgia, Minnesota, North Carolina. The recall was initiated on 11 Oct 2012 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesCAP 394436 to 394663

Quantity recalled7 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-0614-2013
FDA event ID: 63814
Recalling firm: Roche Molecular Systems, Branchburg, NJ
Classification: Class II
Status: Terminated
Recall initiated: 11 Oct 2012
FDA classified: 22 Dec 2012
Reported: 2 Jan 2013
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Medical Software

Timeline

11 Oct 2012	Recall initiated by company
22 Dec 2012	Classified by FDA	+72 days
2 Jan 2013	Published in enforcement report	+11 days

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

Reason for recall

Certain COBAS AmpliPrep instruments using AMPILINK software v.3.3.4 had the sample clot detection flagging feature disabled during quality control release resulting in samples that may not be flagged as having clots.

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

COBAS AmpliPrep Instrument (CAP) with AMPLILINK (AL) Software v.3.3.5 Automated sample processing instrument used with CAP/CA and CAP/CTM. Roche Molecular Systems, Inc. 1080 US Highway 202 South Branchburg, NJ 08876 USA Made in Switzerland

Where it was distributed

Distributed in the states of GA, CA, NC, and MN.

California Georgia Minnesota North Carolina

Questions about this recall

Is Cobas AmpliPrep Instrument (Cap) with Amplilink (AL) recalled?

Yes. Roche Molecular Systems recalled Cobas AmpliPrep Instrument (Cap) with Amplilink (AL) on 11 Oct 2012. The recall is Class II and its status is Terminated. Recall number Z-0614-2013.

Why was it recalled?

Which lots are affected?

CAP 394436 to 394663

Where was it sold?

Distributed in the states of GA, CA, NC, and MN.

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 Roche Molecular Systems

All 42

Reported	Class	Recall	Company	Reason	Where
15 Feb 2023Device	CLASS II	cobas Sars-CoV-2 & Influenza A/B Qualitative assay recalled	Roche Molecular Systems	Lead & Heavy Metals	Nationwide
15 Feb 2023Device	CLASS II	cobas Influenza A/B & RSV UC recalled by Roche Molecular Systems	Roche Molecular Systems	Lead & Heavy Metals	Nationwide
15 Feb 2023Device	CLASS II	cobas Sars-CoV-2 & Influenza A/B Qualitative nucleic acid recalled	Roche Molecular Systems	Lead & Heavy Metals	Nationwide
26 Oct 2022Device	CLASS II	cobas 5800 instrument, Material No. recalled by Roche Molecular Systems	Roche Molecular Systems	Lead & Heavy Metals	Nationwide
6 Apr 2022Device	CLASS II	cobas LiatSystem, respiratory virus panel nucleic acid recalled	Roche Molecular Systems	Potency & Assay	Nationwide

Other Medical Software recalls

All 903

Reported	Class	Recall	Company	Reason	Where
9 Sep 2026Device	CLASS II	Philips Brilliance recalled by Philips North America	Philips North America	Device Malfunction	MA
9 Sep 2026Device	CLASS II	Philips IQon Spectral CT Product Codes recalled by Philips North America	Philips North America	Device Malfunction	MA
9 Sep 2026Device	CLASS II	Philips Ingenuity CT Product Codes recalled by Philips North America	Philips North America	Device Malfunction	MA
9 Sep 2026Device	CLASS II	Philips Brilliance CT 64: Brilliance CT 64 Channel Product recalled	Philips North America	Device Malfunction	MA
8 Sep 2026Device	ANNOUNCED	BMC Luna G3 APAP recalled by BMC MedicalBMC	BMC Medical	Device Malfunction	Nationwide