The Alternans Sensor Kit Assembly is a sealed kit that contains the components necessary for conducting a Microvolt Twave Alternans test.
This recall has been terminated (originally issued June 7, 2010).
- Company
- Cambridge Heart, Inc.
- Recall Initiated
- April 29, 2010
- Posted
- June 7, 2010
- Terminated
- September 20, 2011
- Recall Number
- Z-1776-2010
- Quantity
- 2740
- Firm Location
- Tewksbury, MA
- Official Source
- View on FDA website ↗
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.
Distribution
Nationwide
Lot / Code Info
Alternans Sensor Kits Kit Dispenser Box Lot # 550312 Lot # 5229 Lot # 700104 Lot # 5734 Lot # 700362 Lot # 6343 Lot # 700383 Lot # 6433 Lot # 700585 Lot # 6853 Lot # 700589 Lot# 6966 Lot # 700649 Lot # 7178
Root Cause
Process control
Action Taken
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.