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Siemens Healthcare Diagnostics, Inc. Recall 90559

Description: Atellica CH Iron_2 (Iron_2) is for in vitro diagnostic use in the quantitative determination of iron in human serum and (lithium heparin) plasma samples.

Siemens Healthcare Diagnostics, Inc. Recall 90559 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-1498-2022
Event ID90559
Event DescriptionAtellica CH Iron_2 (Iron_2) is for in vitro diagnostic use in the quantitative determination of iron in human serum and (lithium heparin) plasma samples.
Product TypeDevices
DistributionWorldwide distribution - US Nationwide and the countries of AR, AU, AT, BS, BH, BD, BE, BR, BG, BF, CA, CL, CO, HR, CW, CZ, DK, EC, EG, EE, FI, FR, DE, GR, GP, HK, HU, IN, IR, IQ, IE, IL, IT, JP, JO, KE, KW, LV, LY, LT, MY, MX, MA, NL, NZ, NO, OM, CN, PK, PY, PE, PH, PL, PT, QA, KR, RO, RU, SA, RS, SG, SK, ZA, ES, SE, CH, TW, TH, TR, AE, UG, GB, UY, VA, VN.
Quantity1614 units US ; 7,979 units OUS
Recall ReasonFalsely Elevated Atellica CH Microalbumin_2 (¿ALB_2) Results due to Reagent Carryover from the Iron_2 Assay. This defect occurs only when a microalbumin test is run immediately after an iron test.
Device Classification20220810
Device Code InfoUnique Device Identification (UDI): 00630414596402 All lots
Center Classification Date20220804
Recall Initiation Date20220628
Recalling FirmSiemens Healthcare Diagnostics, Inc.
Initial Notification Letter
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