Reported Aug 21, 2013 · Terminated
ADVIA Centaur Calibrator A. Cat. #04800735, SMN 10285904 (6 pack); Cat. # 04800840, SMN 10285905 (6 pack - REF). For…
Siemens Healthcare Diagnostics, Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.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 Calibrator A. Cat. #04800735, SMN 10285904 (6 pack); Cat. # 04800840, SMN 10285905 (6 pack - REF). For calibrating the following
- assays using the ADVIA Centaur or ACS180
- systems
FT3T3T4TupFT4THEO2
- Lot codes and dates
- REF 10285904 (6 pack)
89983A77 16 Jul 201390669A77 16 Jul 2013REF 10285905 (6 pack - REF)90705A77 16 Jul 2013
- REF 10285904 (6 pack)
- Amount recalled
- 265 Cal A 6 packs (US and OUS)
Where it was sold
Why it was recalled
Calibrator A lot CA77 is under-recovering to the assigned target for the ADVIA Centaur Total T4 Assay.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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