Reported Jul 8, 2015 · Terminated
ICT Serum Calibrator REF 146-03. For use in the calibration of the serum Sodium, Potassium, and Chloride assays.
Abbott Laboratories
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: Abbott Laboratories · 100 Abbott Park Rd · Abbott Park, IL · 60064-3502
Is this the product you have?
- ICT Serum Calibrator REF 146-03. For use in the calibration of the serum Sodium, Potassium, and Chloride assays.
- Lot codes and dates
- Lot numbers21399UN13 (Expiration
- date
5AUG2014)67873UN13 (Expiration
- date
12NOV2014)74710UN13 (Expiration
- date
8DEC2014)82008UN13 (Expiration
- date
14JAN2015)88884UN13 (Expiration
- date4FEB2015)
- Amount recalled
- 11,215 units
Where it was sold
- Nationwide
- PR
Why it was recalled
ICT Serum Calibrator may generate lower than expected Potassium Quality Control (QC) and patient results on the Abbott Architect cSystem.
This product could cause temporary or reversible health problems — stop using it.
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