Z-1776-2010

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

Name: Z-1776-2010 The Alternans Sensor Kit Assembly is a sealed kit that contains the components necessary for conducting a...
Creator: Cambridge Heart, Inc.
Published: 2010-04-29
License: https://open.fda.gov/license/

Cambridge Heart, Inc. / initiated 2010-04-29 / Terminated / root cause: manufacturing process

FDA source

Cambridge Heart, Inc. began a recall of The Alternans Sensor Kit Assembly is a sealed kit that contains the components necessary for conducting a Microvolt Twave Alternans test on 2010-04-29. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1776-2010
Status: Terminated
Initiated: 2010-04-29
Posted: 2010-06-07
Terminated: 2011-09-20
Recalling firm: Cambridge Heart, Inc.
Product: The Alternans Sensor Kit Assembly is a sealed kit that contains the components necessary for conducting a Microvolt Twave Alternans test.
Product code: DRX Electrode, Electrocardiograph
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.
Root cause tag: manufacturing process
FDA root cause: Process control
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.
Quantity in commerce: 2740
Distribution: Nationwide
Product codes and lots: 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

Product code DRX

K002230Class IICambridge Heart Micro-V Alternans Sensor, Model 20327-002Cambridge Heart, Inc. / cleared 2000-08-18

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)