Reported Jan 2, 2019 · Terminated
ABL800 analyzer, model numbers 393-800 and 393-801.
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?
ABL800 analyzermodel numbers 393-800 and 393-801
- Lot codes and dates
- Model 393-800 ABL800 Series w/o Creatinin (All serial numbers)
- for the following configurationsABL800, ABL805, ABL810, ABL815, ABL820, ABL825, ABL830, and ABL835. Model 393-801 ABL800 Series with Creatinin (All serial numbers)
- for the following configurations
ABL817ABL827and ABL837
- Amount recalled
- 2,131 analyzers
Where it was sold
- Nationwide
Why it was recalled
The analyzer software may cause a mis-match of patient demographics and test results when a certain sequence of events occur.
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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