Atellica IM Enhanced Estradiol (eE2) (REF) 500T - In vitro diagnostic use in the quantitative determination of estradiol
Summary
The FDA issued a Class II for Atellica IM Enhanced Estradiol (eE2) (REF) 500T - In vitro diagnostic use in the by Siemens Healthcare Diagnostics, Inc.. Reason: Falsely Elevated Results Observed with Plasma Specimens, could lead a clinician to misinterpret patient results.
Details
Source
Device Recall
External ID
Z-1022-2022
Action Date
2022-05-11
Status
Ongoing
Category
device
Product Description
Atellica IM Enhanced Estradiol (eE2) (REF) 500T - In vitro diagnostic use in the quantitative determination of estradiol SMN: 11206250 All lots
Lot/Code Info: All lot numbers UDI: (01)00630414293639(10)01380084(17)20220804 (01)00630414293639(10)20299080(17)20220303
Quantity Affected: 230 units
Reason for Recall
Falsely Elevated Results Observed with Plasma Specimens, could lead a clinician to misinterpret patient results
Distribution
Worldwide distribution - US Nationwide and the countries of Austria, Belgium, Brazil, Bulgaria, Burkina, Faso Country AG, Cyprus, Denmark, Egypt, Estonia, Finland, France, French Polynesia, Georgia, Greece, Guadeloupe, India, Ireland, Israel, Italy, Kazakhstan, Latvia, Lithuania, Macedonia, Malta, Morocco, Nepal, Netherlands, Norway, Palestinian Ter, Paraguay, Poland, Portugal, Qatar, Romania, Russian Fed., Slovakia, Spain, Sweden, Switzerland, Turkey, Turkmenistan, U.A.E., Ukraine, United Kingdom, Vatican city.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-03-03
Company
East Walpole, MA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 121 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Siemens Healthcare Diagnostics, Inc. has 166 FDA actions in our database, including 142 recalls and 24 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Siemens Healthcare Diagnostics, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Siemens Healthcare Diagnostics, Inc. have FDA actions?
Siemens Healthcare Diagnostics, Inc. has 166 FDA actions in our database, including 142 recalls and 24 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1022-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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