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Terminated

Tecan Genesis RSP and NPS Instruments with barcode scanner type PosID2 option with firmware version 2.45 or lower.

FDA Recall Z-0869-03 · Posted 2003-05-29

Recalling FirmTecan U S Inc
Recall StatusTerminated
Product CodeJQW
Date Initiated2003-02-27
Date Terminated2006-04-06
Product Quantity327 instruments require firmware upgrade.

Reason for Recall

Firmware defect. Under certain conditions a strip rack is no longer in the initial position after a motor overload of the barcode scanner PosID2.

Firm Action

Tecan US notified consignees by registered letter on/about 3/13/2003. International accounts were notified via e-mail 3/13/2003 by Tecan Switzerland. Consignees were advised to contact the firm''s Technical Support line to coordinate the PosID firmware upgrade.

Root Cause

Other

Distribution Pattern

Instruments requiring upgrade were distributed to various clinical laboratories and blood banks Nationwide and World wide .

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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