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Siemens Healthcare Diagnostics, Inc. Recall 90387

Description: Dimension CTNI-In vitro diagnostic test intended to quantitively measure cardiac troponin-I levels in human serum and heparinized plasma to aid in the diagnosis of myocardial infarction. Siemens Material Number (SMN)/REF (Catalog Number): 10444905/RF421C

Siemens Healthcare Diagnostics, Inc. Recall 90387 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-1341-2022
Event ID90387
Event DescriptionDimension CTNI-In vitro diagnostic test intended to quantitively measure cardiac troponin-I levels in human serum and heparinized plasma to aid in the diagnosis of myocardial infarction. Siemens Material Number (SMN)/REF (Catalog Number): 10444905/RF421C
Product TypeDevices
DistributionWorldwide distribution - US Nationwide distribution in the states of AL, AR, CA, MN, MS, NC, ND, NH, OK, SD, TN, TX, WA and the countries of Argentina, Brazil, France, Germany, India, Mexico, Poland, Portugal, Slovakia, Spain.
Quantity113 units
Recall ReasonPositive bias with Lithium Heparin plasma samples from individuals that are expected to be below the 99th percentile of 0.07 ng/mL [0.07 ¿g/L], may lead to inappropriate intervention for myocardial infarction
Device Classification20220713
Device Code InfoUDI-DI: 00842768013836GA232320221119 Lot Number: GA2323 Exp. Date: 11-19-2022
Center Classification Date20220706
Recall Initiation Date20220518
Recalling FirmSiemens Healthcare Diagnostics, Inc.
Initial Notification Letter
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