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Class 2 Device Recall Diamedix IsCMV IgG Test Kit |
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Date Initiated by Firm |
March 26, 2015 |
Create Date |
May 17, 2016 |
Recall Status1 |
Terminated 3 on November 14, 2018 |
Recall Number |
Z-1689-2016 |
Recall Event ID |
73194 |
510(K)Number |
K981163
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Product Classification |
Enzyme linked immunoabsorbent assay, cytomegalovirus - Product Code LFZ
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Product |
Diamedix Is-CMV IgG Test Kit |
Code Information |
Catalog # 720-320 Lot # 10105 Expiration Date January 31, 2016 |
Recalling Firm/ Manufacturer |
Diamedix Corporation 14100 Nw 57th Ct Miami Lakes FL 33014-3107
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For Additional Information Contact |
Yamile Athanasaw 800-327-4565
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Manufacturer Reason for Recall |
Product contained an incorrect substrate.
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FDA Determined Cause 2 |
Other |
Action |
On March 26, 2015 Erba Diagnostics sent a communication to their clients informing them of the recall and sending t hem a replacement sustrate HRP to replaced the wrong one sent on the kit. |
Quantity in Commerce |
150 kits |
Distribution |
AZ, CA, FL, GA, KY, MA, MI, MN, MO, NC, NE, NY, OH, OK, OR, TN, TX, VA, WI and Puerto Rico. |
Total Product Life Cycle |
TPLC Device Report
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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.
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510(K) Database |
510(K)s with Product Code = LFZ and Original Applicant = DIAMEDIX CORP.
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