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Terminated

Tecan Clinical Workstations with Robonet software

FDA Recall Z-1022-04 · Posted 2004-07-20

Recalling FirmTecan U S Inc
Recall StatusTerminated
Product CodeJQW
Date Initiated2004-05-03
Date Terminated2005-05-17
Product Quantity44 units (hardware), 33 units (software)

Reason for Recall

Tecan software has the potential to match the patient with a different patient's test results.

Firm Action

Consignees were notified by letter on May 3, 2004

Root Cause

Other

Distribution Pattern

CA, CT, GA, IL, IN, MA, MD, MI, NJ, NY, PA, TN, TX, VA, & WI.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K953345GENESISTecan U.S., Inc. · 1995-11-21

Official Source

View FDA Recall →

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

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