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U.S. Department of Health and Human Services

Class 2 Device Recall N Latex HCY

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  Class 2 Device Recall N Latex HCY see related information
Date Initiated by Firm January 11, 2017
Create Date February 21, 2017
Recall Status1 Terminated 3 on June 12, 2018
Recall Number Z-1227-2017
Recall Event ID 76251
510(K)Number K052788  
Product Classification Urinary homocystine (nonquantitative) test system - Product Code LPS
Product N Latex HCY REAGENT, REF/Catalog OPAX03 /SMN 10445973 , IVD

Product Usage:
In-vitro diagnostic reagents for the quantitative determination of total homocysteine (HCY) in human serum, heparinized plasma and EDTA plasma by means of particle-enhanced immunonephelometry with BN II and BN ProSpec System. The device can assist in the diagnosis and treatment of patients suspected of having hyperhomocysteinemia and homocystinuria.
Code Information Lot 802907632, Exp. 2017-02-13
Recalling Firm/
Siemens Healthcare Diagnostics, Inc.
511 Benedict Ave
Tarrytown NY 10591-5005
For Additional Information Contact Customer Care Center (US)
Manufacturer Reason
for Recall
The firm confirmed a reduced once-opened and on-board stability for N Latex Homocysteine (HCY) OPAX03 lot 802907632 that may result in erroneously reduced or elevated homocysteine values. The stability issue may lead to higher than expected lot-to-lot variation and an impaired product performance.
FDA Determined
Cause 2
Nonconforming Material/Component
Action URGENT MEDICAL DEVICE RECALL Letter (PP17-005.A.US, dated 1/11/2016) was sent to the sole US consignee via FedEx on 1/11/2017 to notify the customer of the issue. All N Latex HCY OPAX03 lot 802907632 customers are being instructed to discard N Latex HCY OPAX03 lot 802907632. Customers are requested to complete and return the Effectiveness Check questionnaire attached to the UMDR within 30 days. On 1/13/2017, an URGENT MEDICAL DEVICE RECALL letter (PP17-005.B.US, dated 1/13/2017) was sent to the sole US consignee with instructions to discontinue use of and discard the kit lot; complete & return the Field Correction Effectiveness Check/Product Replacement Form attached to this letter within 30 days; Review your inventory of these products to determine your laboratorys replacement needs and to provide information to Siemens for reporting to the authorities. For questions, please contact your Siemens Customer Care Center or your local Siemens technical support representative.
Quantity in Commerce US: 62 kits; Foreign: 290 kits
Distribution Worldwide Distribution - US Nationwide in the state of Colorado and Foreign distribution to the following countries: Austria, Brazil, Canary Islands, Chile, China, Czech Republic, France, Germany, Great Britain (UK), Italy, Kuwait, Latvia, Poland, Saudi Arabia, Spain, Switzerland, Turkey, United Arab Emirates.
Total Product Life Cycle TPLC 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) Database 510(K)s with Product Code = LPS and Original Applicant = DADE BEHRING, INC.