Z-1028-2013Class II

Roche Molecular Systems cobas x 480 System 50 mL reagent reservoir, Catalog number 05232732001. Used with the...

Name: Z-1028-2013 Roche Molecular Systems cobas x 480 System 50 mL reagent reservoir, Catalog number 05232732001. Used with the...
Creator: Roche Diagnostics Operations, Inc.
Published: 2013-03-01
License: https://open.fda.gov/license/

Roche Diagnostics GmbH / initiated 2013-03-01 / Terminated / root cause: manufacturing process

FDA source

Roche Diagnostics Operations, Inc. began a recall of Roche Molecular Systems cobas x 480 System 50 mL reagent reservoir, Catalog number 05232732001. Used with the cobas CT/NG 4800 System, for in vitro diagnostics on 2013-03-01. FDA classified it as Class II and gives the reason as "Certain lots of Reagent reservoirs, may not have a separation in the lower part of the reservoir. As a consequence, pipetting errors can occur due to uneven distribution of reagent. These pipetting errors may lead to...". 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-1028-2013
Classification: Class II
Status: Terminated
Initiated: 2013-03-01
Posted: 2013-04-01
Terminated: 2014-06-04
Recalling firm: Roche Diagnostics GmbH
Product: Roche Molecular Systems cobas x 480 System 50 mL reagent reservoir, Catalog number 05232732001. Used with the cobas CT/NG 4800 System, for in vitro diagnostics.
Product code: OOI Real Time Nucleic Acid Amplification System
Reason for recall: Certain lots of Reagent reservoirs, may not have a separation in the lower part of the reservoir. As a consequence, pipetting errors can occur due to uneven distribution of reagent. These pipetting errors may lead to delayed results and wasted reagent.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Roche sent a Urgent Medical Device Correction letter via UPS to all affected customers ( receipt required) The letter identified the product the problem and the action needed to be taken by the customers. Customers were instructed to visually inspect affected product for the molding defect and to verify equal distribution of reagent in both chambers of the reservoir after adding reagent. All customers are requested to fill out the FAX Back form to schedule shipment of defective part. Non-responding accounts will be monitored on an ongoing basis and follow-up attempts will be made. Questions and concerns are to be addressed to Roche Molecular Diagnostics Technical Support 24 hours/day 1-800-526-1247.
Quantity in commerce: 189 units
Distribution: Nationwide Distribution including Puerto Rico and the states of MO, NE, CO, MT, NJ, FL, WA, TX, GA, NY, KS, NH, VA, HI, PA, MI, IA, CA, NC, AZ, UT, LA, IL, TN, ME, MN, KY, CT, OR, NV, AL and NM.
Product codes and lots: Lot / SN : 477415,477416, 477898, and 477899

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1028-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1028-2013	Class II	Terminated	Voluntary: Firm initiated	2013-04-10	2013-04-01

Product code OOI

K110923Class ICobas 4800 CT / Ng TestRoche Molecular Systems, Inc. / cleared 2012-01-24

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)