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Terminated

The Alternans Sensor Kit Assembly is a sealed kit that contains the components necessary for conducting a Microvolt Twave Alternans test.

FDA Recall Z-1776-2010 · Posted 2010-06-07

Recalling FirmCambridge Heart, Inc.
Recall StatusTerminated
Product CodeDRX
Date Initiated2010-04-29
Date Terminated2011-09-20
Product Quantity2740

Reason for Recall

Some kits contained a component with expiration date prior to the date of expiry on the outside of the kit. The user receives feedback of potential unreliable results at several stages during the test process, so any risk of unreliable results is low.

Firm Action

The Alternate Sensor Kit Assembly P/N 203270209 may contain a pouch of standard ECG electrodes with an expiry date which is earlier than the expiration date on the outside label of the kit. All customers were sent a letter dated April 23, 2010 with information that included instructions for returning the kits. Questions are directed to the company's Quality Manager and Recall Coordinator at phone number 978-654-7625.

Root Cause

Process control

Distribution Pattern

Nationwide

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

Official Source

View FDA Recall →

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

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