Reported Mar 16, 2016 · Terminated
Siemens Healthcare Diagnostics ADVIA Centaur Calibrator E - 2-Pack Catalog Number: 04634452 SMN: 10309079 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 Healthcare Diagnostics ADVIA Centaur
- Calibrator E - 2-Pack Catalog Number04634452
- SMN10309079 ADVIA Centaur¿ Calibrator E For in vitro diagnostic use in calibration the following
- assays using ADVIA Centaur systemsCortisol, Progesterone Testosterone. ADVIA Centaur¿ Testosterone For in vitro diagnostic use in the quantitative determination of total testosterone {bound and unbound) in serum using the ADVIA Centaur and ADVIA Centaur XP Systems
- Lot codes and dates
- Lot codes/Exp Date
87226A42 May 9201655811 A42 May 9201653650A42 May 9201653624A42 May 9201615612A43 November 27201617909A43 November 27201622868A43 November 27201645084A43 November 272016
- Lot codes/Exp Date
- Amount recalled
- 15224 (2-pack)
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
Why it was recalled
ADVIA Centaur Systems Calibrator E Lot 42 and 43 Bias with the Testosterone Assay
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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