Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

Roche MagNA Pure LC Workstation; Product Numbers: 12236931001, 12236931444, 12236931692 and 03670325001. Robotic workstation for automated isolation of nucleic acids from different kinds of crude sample material such as whole blood, serum, blood cells, culture cells, tissue, bacteria and fungi.

FDA Recall Z-1255-2009 · Posted 2009-05-18

Recalling FirmRoche Diagnostics Corp.
Recall StatusTerminated
Product CodeLXG
Date Initiated2009-02-09
Date Terminated2009-12-07
Product Quantity371

Reason for Recall

Protruding screw threads may cut the user when cleaning the interior of the instrument.

Firm Action

In a letter titled "Urgent Medical Device Correction" dated February 9, 2009, consignees were notified of the protruding screws and instructed to use caution when cleaning the instrument until a protective plate is installed by the firm's field representative. Further questions should be addressed to Roche Molecular Diagnostics Technical Support at 1-800-526-1247.

Root Cause

Device Design

Distribution Pattern

Nationwide Distribution including Puerto Rico and states of AL, AR, AZ, CA, CO, CT, DE, FL, GA, HA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NV, NY, OH, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI and WV.

Official Source

View FDA Recall →

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

↑