Reported Oct 5, 2016 · Terminated
Siemens ADVIA Centaur¿ Calibrator U, For in vitro diagnostic use in calibrating the following assays using ADVIA…
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?
- Siemens ADVIA Centaur¿ Calibrator U, For in vitro diagnostic use in calibrating the following assays using ADVIA Centaur"'
- systemsMyoglobin cTnl Cat No. ADVIA Centaur Calibrator U (2 Pack) - 03684480 (SMN 1 0309996)
- Lot codes and dates
- Kit Lots ending in 63 and 64 as follows
65710A6377825A6399481A6408835A6422955A64
- Kit Lots ending in 63 and 64 as follows
- Amount recalled
- 2,248 kits
Where it was sold
- Nationwide
Why it was recalled
Failure of analytical sensitivity with Calibrator U kit lots ending in 63 and 64 and a drift from the internal standardization
This product could cause temporary or reversible health problems — stop using it.
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