Envoy 500 system includes the following product recall
Envoy 500 system includes the following product reference numbers and names: 55345 ENVOY 500 Glucose 55450 ENVOY 500 URIC ACID REAGENT KIT 55435 ENVOY…
Why was Envoy 500 system includes the following product recalled?
ELITech clinical Systems reagents based on Trinder reaction used on the Envoy 500 instrument system are recalled due to potential drug interference. No complaints were received.
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
- Envoy 500 system includes the following product reference numbers and names: 55345 ENVOY 500 Glucose 55450 ENVOY 500 URIC ACID REAGENT KIT 55435 ENVOY…
- Recalling firm
- ELITech Clinical Systems SAS
- Quantity
- 13455 systems
- Distribution
- US Nationwide Distribution
- Recall date
- November 11, 2015
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)