Reported Jul 5, 2017 · Terminated
Access System-GI Monitor (CA19-9), A83873D, Catalog No. 387687
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?
Access System-GI Monitor (CA19-9)A83873DCatalog No. 387687
- Lot codes and dates
- all lots
- Amount recalled
- 249,597 units total (9,388 units in US)
This recall covers 4 products
The agency filed one notice per product. You are reading one of them; the other 3 are below.
Where it was sold
Why it was recalled
The Access immunoassays are susceptible to biotin interference.
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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