Atellica IM Enhanced Estradiol (eE2) (REF) 500T - In vitro diagnostic use in the quantitative determination of estradiol SMN: 11206250 All lots
Reported: May 11, 2022 Initiated: March 3, 2022 #Z-1022-2022
Product Description
Atellica IM Enhanced Estradiol (eE2) (REF) 500T - In vitro diagnostic use in the quantitative determination of estradiol SMN: 11206250 All lots
Reason for Recall
Falsely Elevated Results Observed with Plasma Specimens, could lead a clinician to misinterpret patient results
Details
- Recalling Firm
- Siemens Healthcare Diagnostics, Inc.
- Units Affected
- 230 units
- 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.
- Location
- East Walpole, MA
Frequently Asked Questions
What product was recalled? ▼
Atellica IM Enhanced Estradiol (eE2) (REF) 500T - In vitro diagnostic use in the quantitative determination of estradiol SMN: 11206250 All lots. Recalled by Siemens Healthcare Diagnostics, Inc.. Units affected: 230 units.
Why was this product recalled? ▼
Falsely Elevated Results Observed with Plasma Specimens, could lead a clinician to misinterpret patient results
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 11, 2022. Severity: Moderate. Recall number: Z-1022-2022.
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