Phadia 1000 Instrument recall
Phadia 1000 Instrument, Article Number 12-3800-01.
Why was Phadia 1000 Instrument recalled?
The "Retry" command does not function properly which could cause a shortage of Wash and Rinse solution and affect assay performance and test 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 versions of the instrument
- Product
- Phadia 1000 Instrument, Article Number 12-3800-01.
- Recalling firm
- Phadia US Inc
- Quantity
- 70 units
- Distribution
- Nationwide
- Recall date
- January 24, 2018
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)