CoaguChek XS Pro System The CoaguChek XS Pro System recall
CoaguChek XS Pro System The CoaguChek XS Pro System (CoaguChek XS Pro meter and CoaguChek XS PT Test strips) quantitatively determines prothrombin…
Why was CoaguChek XS Pro System The CoaguChek XS Pro 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: 05530199160
- Product
- CoaguChek XS Pro System The CoaguChek XS Pro System (CoaguChek XS Pro meter and CoaguChek XS PT Test strips) quantitatively determines prothrombin…
- Recalling firm
- Roche Diagnostics Operations, Inc.
- Quantity
- 537 meters total
- Distribution
- Nationwide Distribution
- Recall date
- July 3, 2013
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)