CoaguChek XS System recall
CoaguChek XS System (PST) The CoaguChek XS PT test strips are part of the CoaguChek XS System. The CoaguChek XS System measures blood-clotting time…
Why was CoaguChek XS System recalled?
Roche has confirmed the potential for an undetected elevated INR test result with the CoaguChek XS, CoaguChek XS Plus, and CoaguChek XS Pro meters. In rare cases, instead of a value, an ERROR 6 message is displayed.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Model/Catalog/Part Number: 04837738001
- Product
- CoaguChek XS System (PST) The CoaguChek XS PT test strips are part of the CoaguChek XS System. The CoaguChek XS System measures blood-clotting time…
- Recalling firm
- Roche Diagnostics Operations, Inc.
- Quantity
- 204,205 meters total
- Distribution
- Nationwide Distribution
- Recall date
- July 3, 2013
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)