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

FDA device recall Z-0297-2016 · posted 2015-11-18 · Terminated

Recall details

Recalling firm

Roche Diagnostics Operations, Inc.

Reason for recall

Possible for sample tubes in the loader to be opened and contaminate the system as well as adjacent samples during processing.

Action taken

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.

Root cause

Device Design

Status

Terminated

Product code

JQP

Quantity affected

1

Distribution

Distributed to TX only.

Date initiated

2015-09-22

Date posted

2015-11-18

Date terminated

2016-02-03

Location

Indianapolis, IN