ADVIA Centaur CKMB Calibrator 2-pack Japan recall
ADVIA Centaur CKMB Calibrator 2-pack Japan, Cat No. 02562748 Product Usage: For in vitro diagnostic use in calibrating ADVIA Centaur systems CKMB…
Why was ADVIA Centaur CKMB Calibrator 2-pack Japan recalled?
A potential bias was identified with certain kits compared to the internal standards.
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?
SMN 10333512 Lot # Expiry UDI # 58311A67 2018-Dec-11 (01)00630414056890(10)58311A67(17)20181211 97468A67 2018-Dec-11 (01)00630414056890(10)97468A67(17)20181211
- Product
- ADVIA Centaur CKMB Calibrator 2-pack Japan, Cat No. 02562748 Product Usage: For in vitro diagnostic use in calibrating ADVIA Centaur systems CKMB…
- Recalling firm
- Siemens Healthcare Diagnostics, Inc
- Quantity
- 69 kits
- Distribution
- US Nationwide Distribution
- Recall date
- October 24, 2018
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)