CoaguChek XS PST Meters- IVD recall
CoaguChek XS PST Meters- IVD (Patient Self-Testing) measures blood-clotting time for people who are taking anticoagulation medications such as…
Why was CoaguChek XS PST Meters- IVD recalled?
Possible Misinterpretation of Displayed Measuring Units from INR to %Quick or Seconds; providing instructions to users for ensuring the meter is displaying INR results
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?
All serial numbers
- Product
- CoaguChek XS PST Meters- IVD (Patient Self-Testing) measures blood-clotting time for people who are taking anticoagulation medications such as…
- Recalling firm
- Roche Diagnostics Operations, Inc.
- Quantity
- 716,880 units
- Distribution
- US Nationwide
- Recall date
- January 13, 2021
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)