Devices

ADVIA Centaur CKMB Calibrator Bias and Out of Range Results Using Master Curve Material (MCM)

Model / Serial
ADVIA Centaur CKMB Calibrator : 09318028 : 10311570 Lot : 57834A64, 57835A64, 72519A64, 98115A64 ADVIA Centaur CKMB MCM : 07867768 : 10309782 Lot: 35061 ......................................... FDA update codes: ADVIA Centaur CKMB Calibrator 2-pack Japan, Cat No. 02562748 SMN 10333512 Lot # Expiry UDI # 58311A67 2018-Dec-11 (01)00630414056890(10)58311A67(17)20181211 97468A67 2018-Dec-11 (01)00630414056890(10)97468A67(17)20181211 Atellica IM CKMB Master Curve Material, Cat No. 10995534 SMN 10995534 Lot # Expiry UDI # 11803 2019-02-10 (01)00630414598611(10)11803(17)20190210 Atellica IM CKMB Calibrator, Cat No. 10995532 SMN 10995532 Lot # Expiry UDI # 57837A66 2018-12-11 (01)00630414598598(10)57837A66(17)20181211 67443A66 2018-12-11 (01)00630414598598(10)67443A66(17)20181211
Product Description
IVDs
Manufacturer
Siemens Healthcare Diagnostics GmbH
1 Event
- translation missing: en.activerecord.attributes.event.titles.recall_field_safety_notice

Manufacturer

Siemens Healthcare Diagnostics GmbH

Manufacturer Parent Company (2017)
Siemens Ag
Manufacturers representative
ABDULREHMAN AL GOSAIBI GTB
Source
SFDA

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