Z-0614-2013Class II

COBAS AmpliPrep Instrument (CAP) with AMPLILINK (AL) Software v.3.3.5 Automated sample processing instrument...

Name: Z-0614-2013 COBAS AmpliPrep Instrument (CAP) with AMPLILINK (AL) Software v.3.3.5 Automated sample processing instrument...
Creator: Roche Molecular Systems, Inc.
Published: 2012-10-11
License: https://open.fda.gov/license/

Roche Molecular Systems Inc / initiated 2012-10-11 / Terminated / root cause: design

FDA source

Roche Molecular Systems, Inc. began a recall of 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... on 2012-10-11. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0614-2013
Classification: Class II
Status: Terminated
Initiated: 2012-10-11
Posted: 2012-12-23
Terminated: 2013-09-11
Recalling firm: Roche Molecular Systems Inc
Product: 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
Product code: JJH Clinical Sample Concentrator
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.
Root cause tag: design
FDA root cause: Device Design
Action: Roche sent an Urgent Medical Device Correction notification/Fax Back forms dated 10/11/12 to potentially affected customers. The letter identified the affected product, the issue, clinical significance, workaround, and required actions, along with contact information. Customers are to use the workaround until their Roche FSE has performed a Master Initialization on their affected instruments. Also, the letter should be filed for future reference. Questions should be directed to Roche Molecular Diagnostics Technical Support at 1-800-526-1247.
Quantity in commerce: 7 units
Distribution: Distributed in the states of GA, CA, NC, and MN.
Product codes and lots: CAP 394436 to 394663

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0614-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0614-2013	Class II	Terminated	Voluntary: Firm initiated	2013-01-02	2012-12-22

Product code JJH

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)