Reported Jul 19, 2017 · Terminated

Beckman Coulter Synchron AQUA CAL Level 1, Part No. 471288 Product Usage: Used for the system calibration of Na, K, Cl,…

Beckman Coulter 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: Beckman Coulter Inc · 250 S Kraemer Blvd · Brea, CA · 92821-6232

Is this the product you have?

    • Beckman Coulter Synchron AQUA CAL Level 1
    • Part No. 471288
  • Product UsageUsed for the system calibration of Na, K, Cl, Urea N, Urea, Glucose Creatine, Ca, CO2, and P in UniCel DxC Systems
Lot codes and dates
    • Lot No. 72645074
    • Exp. Date 30 Apr 2018
Amount recalled
4444 AQUA CAL Level 1 kits

Where it was sold

Why it was recalled

The firm identified a negative shift of 5mmol/L for sodium recovery in Synchron Control Level 3 when calibrated with AQUA Cal 1.

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 Sep 9, 2020 · Data as of Sep 19, 4:47 PM UTC

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