Siemens ADVIA Centaur¿ Calibrator U recall
Siemens ADVIA Centaur¿ Calibrator U, For in vitro diagnostic use in calibrating the following assays using ADVIA Centaur"' systems: Myoglobin cTnl Cat…
Why was Siemens ADVIA Centaur¿ Calibrator U recalled?
Failure of analytical sensitivity with Calibrator U kit lots ending in 63 and 64 and a drift from the internal standardization
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?
Kit Lots ending in 63 and 64 as follows: 65710A63, 77825A63, 99481A64, 08835A64, 22955A64
- Product
- Siemens ADVIA Centaur¿ Calibrator U, For in vitro diagnostic use in calibrating the following assays using ADVIA Centaur"' systems: Myoglobin cTnl Cat…
- Recalling firm
- Siemens Healthcare Diagnostics, Inc
- Quantity
- 2,248 kits
- Distribution
- Worldwide Distribution - Nationwide Distribution including the countries of: Argentina Australia Brazil Canada Chile China Ecuador India Japan Korea Mexico Malaysia Peru Philippines Saudi Arabia Singapore Taiwan Vietnam South Africa
- Recall date
- October 5, 2016
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)