ADVIA Centaur Calibrator 30 recall
ADVIA Centaur Calibrator 30, 2 pack, 6 pack, and Ref 2 pack. Siemens Material Number (SMN): 10379810, 10379811, 10697756.
Why was ADVIA Centaur Calibrator 30 recalled?
Siemens Healthcare Diagnostics has confirmed a negative bias for ADVIA Centaur Enhanced Estradiol (eE2) on the ADVIA Centaur, ADVIA Centaur XP and ADVIA Centaur XPT systems when calibrating with Calibrator 30 kit lots ending in 21 (C3021) as compared to Calibrator 30 kit lots ending in 20 (C3020).
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?
Lot Numbers: 00387A21, 16673A21, 36243A21; 00388A21, 15448A21, 51211A21; 20640A21; 51024A21. Expiration Date: 2018-03-08
- Product
- ADVIA Centaur Calibrator 30, 2 pack, 6 pack, and Ref 2 pack. Siemens Material Number (SMN): 10379810, 10379811, 10697756.
- Recalling firm
- Siemens Healthcare Diagnostics, Inc
- Quantity
- 5992 units (US and OUS)
- Distribution
- US and OUS.
- Recall date
- February 14, 2018
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)