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Terminated

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.

FDA Recall Z-0297-2016 · Posted 2015-11-18

Recalling FirmRoche Diagnostics Operations, Inc.
Recall StatusTerminated
Product CodeJQP
Date Initiated2015-09-22
Date Terminated2016-02-03
Product Quantity1

Reason for Recall

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

Firm 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.

Root Cause

Device Design

Distribution Pattern

Distributed to TX only.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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