Online TDM Vancomycin Gen.3 recall
Online TDM Vancomycin Gen.3 (100 tests) Catalog # 06779336190 Analyzer/Module: cobas c 311 and cobas c 501/502
Why was Online TDM Vancomycin Gen.3 recalled?
Inaccurately Low Sample 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 Lots
- Product
- Online TDM Vancomycin Gen.3 (100 tests) Catalog # 06779336190 Analyzer/Module: cobas c 311 and cobas c 501/502
- Recalling firm
- Roche Diagnostics Operations, Inc.
- Quantity
- 27676 units
- Distribution
- AK AL AR AZ CA CO CT DC DE FL GA GU HI IA ID IL IN KS KY LA MA MD ME MI MN MO MS MT NC ND NE NH NJ NM NV NY OH OK OR PA PR RI SC SD TN TX UT VA VT WA WI WV WY
- Recall date
- October 16, 2019
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)