Reported Nov 12, 2014 · Terminated

Siemens Calibrator E; SMN 10309079 (2 pack), SMN 10321075 (6 pack), SMN 10335532 (6 pack Ref)

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 Calibrator E
    • SMN 10309079 (2 pack)
    • SMN 10321075 (6 pack)
    • SMN 10335532 (6 pack Ref)
Lot codes and dates
    • 26284A38
    • 26900A38
    • 27991A38
    • 28192A38
    • 29571A38
    • 31162A38
    • 32488A38
    • 35243AB39
    • 35295AB39
    • 36091AB39
    • 39464AB39
    • 40245AB39
    • 41317AB39
    • 26285A38
    • 27348A38
    • 29169A38
    • 30710A38
    • 31261A38
    • 32687A38
    • 35259AB39
    • 35359AB39
    • 36289AB39
    • 39031AB39
    • 41124AB39
    • 27236A38
    • 35051A38
    • 35839AB39
    • 40141AB39
    • 41702AB39
Amount recalled
Total = 19,352 (13,881 - 2 pack, 4878 - 6 pack, 593 - 6 pack REF)

Where it was sold

Why it was recalled

Positive bias for Calibrator E lot kits ending in 38 and 39 with the ADVIA Centaur Systems Cortisol and Progesterone assays compared to the respective master curves.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Jan 29, 2016 · Data as of Sep 19, 4:46 PM UTC

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