Reported Mar 22, 2017 · Terminated
The ABL800 Model#:All
Radiometer America 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: Radiometer America Inc · 250 S Kraemer Blvd · Brea, CA · 92821-6232
Is this the product you have?
- The ABL800 Model#:All
- Lot codes and dates
- The affected analyzers are serial numbers 393-090R0027N001 to present.
- Amount recalled
- 17,522
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
Why it was recalled
Reports that the sample type "cord blood" has been changed into the two sample types "cord blood arterial" and "cord blood venous.
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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