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U.S. Department of Health and Human Services

Class 2 Device Recall

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 Class 2 Device Recallsee related information
Date Initiated by FirmMarch 21, 2018
Create DateJuly 13, 2018
Recall Status1 Terminated 3 on June 12, 2020
Recall NumberZ-2436-2018
Recall Event ID 79784
510(K)NumberK081643 
Product Classification Immunoassay method, troponin subunit - Product Code MMI
ProductDimension Vista CTNI Sample Diluent, KD692, SMN# 10445205
Code Information lot # 17171BD, UDI # (UDI) 008427680158927BDA3418060110445205
Recalling Firm/
Manufacturer		 Siemens Healthcare Diagnostics, Inc.
500 Gbc Dr Ms 514
Po Box 6101
Newark DE 19702-2466
For Additional Information Contact
800-441-9250
Manufacturer Reason
for Recall		The diluent may have an incomplete slit on the septum in the cap of the vial. A diluent cap with a defective septum has the potential to cause erroneously elevated results if a sample is autodiluted onboard the system, due to a reduced volume of diluent being pipetted from the vial.
FDA Determined
Cause 2		Under Investigation by firm
ActionNotification letters were distributed 3/21/18. The letters instructed customers to: Inspect stock, discontinue use of and discard the Dimension Vista Diluent lots listed in Table 1. Please review this letter with your Medical Director. Review your inventory of these products to determine your laboratorys replacement needs and to provide information to Siemens for reporting to the authorities. Complete and return the Field Correction Effectiveness Check Form attached to this letter within 30 days. If you have received any complaints of illness or adverse events associated with the product listed in Table 1, immediately contact your local Siemens Customer Care Center or your local Siemens Technical Support Representative. Please retain this letter with your laboratory records, and forward this letter to those who may have received this product.
Quantity in Commerce1446
DistributionThe products were distributed to the following US states: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY. The products were distributed to Guam, Saipan, and Virgin Islands. The products were distributed to the following countries: Australia, Austria, Bahamas, Belgium, Brazil, Canada, Canary Islands, Croatia, Czech Republic, Denmark, France, Germany, Italy, Japan, Lebanon, Netherlands, Poland, Portugal, Qatar, Russian Federation, Slovakia, Slovenia, Saudi Arabia, South Korea, Spain, Switzerland, and United Arab Emirates.
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 = MMI
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