—#141086

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.

FDA product code: JQP — Calculator/Data Processing Module, For Clinical Use
Device class: Class 1
Medical specialty: Clinical Chemistry
Affected lot / code info: 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.

Why it was recalled

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

Root cause (FDA determination)

Device Design

Action the firm took

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.

Recalling firm

Firm: Roche Diagnostics Operations, Inc.
Address: 9115 Hague Rd, Indianapolis, Indiana 46256-1025

Distribution

Distribution pattern: Distributed to TX only.

Timeline

Recall initiated: 2015-09-22
Posted by FDA: 2015-11-18
Terminated: 2016-02-03
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #141086. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.