Z-1459-2011

COBAS AmpliPrep/COBAS TaqMan HBV v2.0 US-IVD; COBAS AmpliPrep/COBAS TaqMan HBV v2.0 CE-IVD

Name: Z-1459-2011 COBAS AmpliPrep/COBAS TaqMan HBV v2.0 US-IVD; COBAS AmpliPrep/COBAS TaqMan HBV v2.0 CE-IVD
Creator: Roche Molecular Systems, Inc.
Published: 2010-12-28
License: https://open.fda.gov/license/

Roche Molecular Systems Inc / initiated 2010-12-28 / Terminated / root cause: manufacturing process

FDA source

Roche Molecular Systems, Inc. began a recall of COBAS AmpliPrep/COBAS TaqMan HBV v2.0 US-IVD; COBAS AmpliPrep/COBAS TaqMan HBV v2.0 CE-IVD on 2010-12-28. The reason FDA records is "There is an issue regarding liquid level detection of the CS1 Magnetic Glass Particles (MGP) Reagent Cassette of the COBAS AmpliPrep /COBAS TaqMan HBV v2.0 Test on the COBAS AmpliPrep instrument". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1459-2011
Status: Terminated
Initiated: 2010-12-28
Posted: 2011-03-01
Terminated: 2012-08-27
Recalling firm: Roche Molecular Systems Inc
Product: COBAS AmpliPrep/COBAS TaqMan HBV v2.0 US-IVD; COBAS AmpliPrep/COBAS TaqMan HBV v2.0 CE-IVD
Product code: MKT Hepatitis Viral B Dna Detection
Reason for recall: There is an issue regarding liquid level detection of the CS1 Magnetic Glass Particles (MGP) Reagent Cassette of the COBAS AmpliPrep /COBAS TaqMan HBV v2.0 Test on the COBAS AmpliPrep instrument.
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: Roche sent Urgent Medical Device Correction Letters to their consignees on December 28, 2010 via Fed Ex. The letters advise the customers to verify the correct configuration of the CSI reagent cassette, remind customers to follow the package insert instructions for including all required controls for each batch and advise that review of previously generated results may be warranted. A UMDC Faxback form was attached for the consignee to complete. For questions regarding this recall call 908-253-7569.
Quantity in commerce: 93 kits to US; 22,119 kits to foreign
Distribution: Worldwide Distribution - USA including CA, CT, IN, MI, MN, NC, NE, NY, OR, TX, WA, and WI and the countries of Australia, Austria, Azerbaijan, Belgium, Brazil, Canada, China, Croatia, Czech Republic, Egypt, Finland, France, Germany, Ghana, Greece, Hong Kong, India, Israel, Italy, Japan, Kuwait, Luxembourg, Malaysia, Mauritania, Mongolia, Netherlands, New Zealand, Norway, Poland, Romania, Saudi Arabia, Singapore, Slovakia, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Thailand, Turkey, United Arab Emirates, and the United Kingdom
Product codes and lots: Catalog number 05027012190, 05393850190, 05393850190, 05393868190 Lot #K11236, K15440, L00846, M05135, M11190, M12625, M14232, N00159, N02341, N05553, N05554, N07543, N08567

Product code MKT

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)