ADVIA Chemistry Systems Drug Calibrator I recall
ADVIA Chemistry Systems Drug Calibrator I; For in vitro diagnostic use in the calibration of Phenobarbital_2 (PHNB_2), Phenytoin_2 (PHNY_2), and…
Why was ADVIA Chemistry Systems Drug Calibrator I recalled?
Incorrect calibrator lot values were assigned for ADVIA Chemistry Systems Drug Calibrator I, lot 3JD018, for the ADVIA Chemistry Systems Phenytoin 2 (PHNY_2) and Phenobarbital 2 (PHNB_2) assays which was the result of calibrator value miscalculation.
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?
Material Number 10376770, Lot Number 3JD018, Expiration: April 2015
- Product
- ADVIA Chemistry Systems Drug Calibrator I; For in vitro diagnostic use in the calibration of Phenobarbital_2 (PHNB_2), Phenytoin_2 (PHNY_2), and…
- Recalling firm
- Siemens Healthcare Diagnostics, Inc.
- Quantity
- 657
- Distribution
- Worldwide Distribution - US (nationwide) and Internationally to Canada and Mexico.
- Recall date
- April 1, 2015
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)