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U.S. Department of Health and Human Services

Class 2 Device Recall BN ProSpec System (Albumin)

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 Class 2 Device Recall BN ProSpec System (Albumin)see related information
Date Initiated by FirmJune 27, 2019
Create DateAugust 22, 2019
Recall Status1 Terminated 3 on May 27, 2020
Recall NumberZ-2341-2019
Recall Event ID 83311
510(K)NumberK001647 
Product Classification Nephelometer - Product Code JZW
ProductN Cuvette Segments for BN ProSpec System-IVD a system for the quantitative determination of proteins in serum, plasma, urine and CSF. Siemens Material Number (SMN):10446539
Code Information Lot # 5890128326 and Lot # 182670004 UDI: 00842768012334
Recalling Firm/
Manufacturer		 Siemens Healthcare Diagnostics, Inc.
511 Benedict Ave
Tarrytown NY 10591-5005
For Additional Information ContactSAME
914-631-8000
Manufacturer Reason
for Recall		Iincreased (falsely elevated) Albumin results compared to expected results
FDA Determined
Cause 2		Process change control
ActionSiemens Healthcare Diagnostics issued Urgent Medical Device Correction (UMDC) letter PP-19-002.A.US to the US customers June 27, 2019 and May 2019 via FedEx overnight delivery and email to regional countries for implementation Outside the US (OUS). Customers were instructed to contact their Siemens Healthineers Customer Care Center for further follow-up in case they experienced sporadically increased Albumin results compared to expected results. Customers were also instructed to complete and return the Field Correction Effectiveness Check Form attached to the letter within 30 days.
Quantity in Commerce664 units
DistributionNationwide
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 = JZW
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