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U.S. Department of Health and Human Services

Class 2 Device Recall ADVIA Chemistry Calibrator

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 Class 2 Device Recall ADVIA Chemistry Calibratorsee related information
Date Initiated by FirmJune 05, 2020
Create DateJune 26, 2020
Recall Status1 Terminated 3 on November 18, 2021
Recall NumberZ-2430-2020
Recall Event ID 85844
510(K)NumberK050374 
Product Classification Assay, porphyrin, spectrophotometry, lithium - Product Code NDW
ProductADVIA Chemistry Calibrator
Code Information Lots: 534177 (including sublots A, B and C) 960742  UDI: (01)00630414223414(10)534177(17)20210930 (01)00630414223414(10)534177A(17)20211031 (01)00630414223414(10)534177B(17)20211231 (01)00630414223414(10)534177C(17)20220131 (01)00630414223414(10)534177D(17)20220331 (01)00630414223414(10)960742(17)20220531
FEI Number 2432235
Recalling Firm/
Manufacturer		 Siemens Healthcare Diagnostics, Inc.
511 Benedict Ave
Tarrytown NY 10591-5005
For Additional Information Contact
312-275-7795
Manufacturer Reason
for Recall		Calibration errors have been observed with the Total and Direct Bilirubin assays when using Chemistry Calibrator lot 534177 for ADVIA Chemistry and lot 534179 for Atellica CH.
FDA Determined
Cause 2		Nonconforming Material/Component
ActionSiemens Healthcare Diagnostics sent a letter notification sent to customers dated June 10, 2020. As one of the short-term alternatives for customers, where regulations permit, Siemens has evaluated the use of the lyophilized RANDOX Calibration Serum Level 3 Lot 1024UE. (CAL 3) for generating DBIL_2/DBil_2 and TBIL_2/TBil_2 results until a new lot of unaffected Siemens Chemistry Calibrator is available.
Quantity in Commerce1872 units
DistributionUS Nationwide Distribution
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = NDW
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