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Siemens Healthcare Diagnostics, Inc. Recall 89740

Description: Atellica CH Enzymatic Hemoglobin A1c (A1c_E/A1c_H), Siemens Material Number 11097536

Siemens Healthcare Diagnostics, Inc. Recall 89740 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-0929-2022
Event ID89740
Event DescriptionAtellica CH Enzymatic Hemoglobin A1c (A1c_E/A1c_H), Siemens Material Number 11097536
Product TypeDevices
DistributionGlobal Distribution. US Nationwide.
Quantity6606
Recall ReasonSiemens Healthcare Diagnostics Inc. has confirmed the potential for reagent carryover impacting quality control (QC), patient samples, and calibrator results.
Device Classification20220420
Device Code InfoUDI: 00630414220505; Lot Numbers: 110027 110060 110065 110091 110113 110129 110137 110161 110170 110208 110224 110234 110235 110262 110265 110273 110286 110315 110330 110347 110360
Center Classification Date20220414
Recall Initiation Date20220209
Recalling FirmSiemens Healthcare Diagnostics, Inc.
Initial Notification Letter
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