enGen (TM) Laboratory Automation System Configured with TCAutomation" Software v3.5 -- For in vitro quantitative measure

FDA device recall Z-1741-2014 · posted 2014-06-10 · Terminated

Recall details

Recalling firm

Ortho-Clinical Diagnostics

Reason for recall

Software anomaly: potential buffer timeout issues when using enGen (TM) Laboratory Automation Systems Configured with TCAutomation (TM) Software v3.5.

Action taken

Ortho Clinical Diagnostics sent an Important Product Correction Notification dated April 17, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. On April 17, 2014, foreign affiliates were informed by e-mail of the issue and instructed to notify their customers of the issue and actions. The letters instruct customers: to ensure that samples prematurely routed to Check are detected and processed appropriately, please monitor completion of all pending tests following standard laboratory practice. Customers were informed of the issue and advised to: -- Routinely monitor pending result reports from your Laboratory Information System (LIS) to determine if results are pending for samples. -- Investigate to determine the next action identified for a sample if the sample is routed to the Check location prematurely. If you have any additional questions, please call Customer Technical Services at 1-800-421-3311.

Root cause

Software Design Change

Status

Terminated

Product code

JJE

Quantity affected

Domestic: 6 units, Foreign: 3 units

Distribution

Worldwide Distribution - US including the states of Arizona, Delaware, Ohio, Tennessee, and North Carolina; and the countries of Mexico, England and Italy.

Date initiated

2014-04-17

Date posted

2014-06-10

Date terminated

2017-04-11

Location

Rochester, NY

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