Reported Oct 24, 2018 · Terminated
ADVIA Centaur CKMB Calibrator, Cat No. 09318028 Product Usage: For in vitro diagnostic use in calibrating ADVIA Centaur…
Siemens Healthcare Diagnostics, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Siemens Healthcare Diagnostics, Inc · 333 Coney St · East Walpole, MA · 02032-1516
Is this the product you have?
- ADVIA Centaur CKMB Calibrator, Cat No. 09318028
- Product UsageFor in vitro diagnostic use in calibrating ADVIA Centaur systems CKMB assays
- Lot codes and dates
- SMN 10311570 Lot # Expiry UDI # 57834A64 2018-Dec-11 (01)00630414124803(10)57834A64(17)20181211 57835A64 2018-Dec-11 (01)00630414124803(10)57835A64(17)20181211 72519A64 2018-Dec-11 (01)00630414124803(10)72519A64(17)20181211 98115A64 2018-Dec-11 (01)00630414124803(10)98115A64(17)20181211
- Amount recalled
- 1870 kits
This recall covers 5 products
The agency filed one notice per product. You are reading one of them; the other 4 are below.
Where it was sold
- Nationwide
Why it was recalled
A potential bias was identified with certain kits compared to the internal standards.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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