Recall Z-1021-2022— Siemens Healthcare Diagnostics, Inc.
Class II · Ongoing
Class II FDA medical device recall by Siemens Healthcare Diagnostics, Inc., initiated 2022-03-03. FDA's recall record names no specific 510(k) clearance for this event. Product: Atellica IM Enhanced Estradiol (eE2) 500T - In vitro diagnostic use in the quantitative determination of estradiol SMN: 10995562 All lots. Reason: Falsely Elevated Results Observed with Plasma Specimens, could lead a clinician to misinterpret patient results.
- Recalling firm
- Siemens Healthcare Diagnostics, Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2022-03-03
- Firm location
- East Walpole, MA, United States
Product description
Atellica IM Enhanced Estradiol (eE2) 500T - In vitro diagnostic use in the quantitative determination of estradiol SMN: 10995562 All lots
Reason for recall
Falsely Elevated Results Observed with Plasma Specimens, could lead a clinician to misinterpret patient results
Data sourced from openFDA. This site is unofficial and independent of the FDA.