FDAFDA · Food and drugs·Recall number Z-0116-2019
Atellica IM CKMB Calibrator, Cat No. 10995532 Product Usage: For in vitro diagnostic use for evaluating the ADVIA Centaur CKMB assay. This material is intended to be run singly as unknown samples after a two-point calibration has been performed on the system.
Published October 24, 2018 · Recall initiated: July 24, 2018
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
A potential bias was identified with certain kits compared to the internal standards.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Siemens Healthcare Diagnostics, Inc
- Distributor
- US Nationwide Distribution
- Lot
- SMN 10995532 Lot # Expiry UDI # 57837A66 2018-12-11 (01)00630414598598(10)57837A66(17)20181211 67443A66 2018-12-11 (01)00630414598598(10)67443A66(17)20181211
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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