Z-0297-2016Class II

Bulk Loader Module for cobas p 512/612 Pre-analytical sample handling that includes de-capping, aliquoting...

Name: Z-0297-2016 Bulk Loader Module for cobas p 512/612 Pre-analytical sample handling that includes de-capping, aliquoting...
Creator: Roche Diagnostics Operations, Inc.
Published: 2015-09-22
License: https://open.fda.gov/license/

Roche Diagnostics GmbH / initiated 2015-09-22 / Terminated / root cause: design

FDA source

Roche Diagnostics Operations, Inc. began a recall of Bulk Loader Module for cobas p 512/612 Pre-analytical sample handling that includes de-capping, aliquoting and sorting of samples for analysis. In vitro... on 2015-09-22. FDA classified it as Class II and gives the reason as "Possible for sample tubes in the loader to be opened and contaminate the system as well as adjacent samples during processing". 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-0297-2016
Classification: Class II
Status: Terminated
Initiated: 2015-09-22
Posted: 2015-11-18
Terminated: 2016-02-03
Recalling firm: Roche Diagnostics GmbH
Product: Bulk Loader Module for cobas p 512/612 Pre-analytical sample handling that includes de-capping, aliquoting and sorting of samples for analysis. In vitro diagnostic machine component.
Product code: JQP Calculator/Data Processing Module, For Clinical Use
Reason for recall: Possible for sample tubes in the loader to be opened and contaminate the system as well as adjacent samples during processing.
Root cause tag: design
FDA root cause: Device Design
Action: Roche Diagnostics Operations, Inc. sent an Urgent Medical Device Correction letter to affected consignees. The letter identified the product, the problem, and the action to be taken by the consignee. Consignees were asked to retain the Urgent Medical Device Correction letter until a Roche Field Service Representative has installed the BLM modification kit. Consignees were also asked to complete the attached form and fax to 1-877-906-8982, ext 2015. Consignees with questions were instructed to call 1-800-428-2336. For questions regarding this recall call 317-521-3911.
Quantity in commerce: 1
Distribution: Distributed to TX only.
Product codes and lots: During transport from the Bulk Loader Module (BLM), catalog number 07135645001, to the cobas p 512/p 612 pre-analytical instruments, sample tubes may inadvertently open and spill, causing contamination of the system.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0297-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0297-2016	Class II	Terminated	Voluntary: Firm initiated	2015-11-25	2015-11-18

Product code JQP

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)