Product Safety Recalls

Product Recall Tracker

Siemens Healthcare Diagnostics, Inc. Recall 89953

Description: Atellica IM Enhanced Estradiol (eE2) 500T - In vitro diagnostic use in the quantitative determination of estradiol SMN: 10995562 All lots

Siemens Healthcare Diagnostics, Inc. Recall 89953 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-1021-2022
Event ID89953
Event DescriptionAtellica IM Enhanced Estradiol (eE2) 500T - In vitro diagnostic use in the quantitative determination of estradiol SMN: 10995562 All lots
Product TypeDevices
DistributionWorldwide 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.
Quantity374 units
Recall ReasonFalsely Elevated Results Observed with Plasma Specimens, could lead a clinician to misinterpret patient results
Device Classification20220511
Device Code InfoAll lot numbers UDI: 01)00630414598864(10)10054080(17)20220303 (01)00630414598864(10)10979086(17)20221107 (01)00630414598864(10)53378082(17)20220521 (01)00630414598864(10)70532084(17)20220804
Center Classification Date20220429
Recall Initiation Date20220303
Recalling FirmSiemens Healthcare Diagnostics, Inc.
Initial Notification Letter
Similar To

© 2021 Recall.Report / Contact / Privacy Policy

This site's data is aggregated programmatically and provided "as is" without any representations or warranties, express or implied.
Recall.report is not affiliated with the Consumer Product Safety Commision, FDA, or US government in any way.