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Class 2 Device Recall A1CNow Systems |
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Date Initiated by Firm |
December 02, 2016 |
Create Date |
December 13, 2019 |
Recall Status1 |
Terminated 3 on July 16, 2020 |
Recall Number |
Z-0682-2020 |
Recall Event ID |
84231 |
510(K)Number |
K090413
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Product Classification |
Assay, glycosylated hemoglobin - Product Code LCP
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Product |
A1CNow+ Systems (professional use product), Software Version Revision D, REF Numbers US: 3021, 3024; EU: 3037, 3038, 3057, 3058 |
Code Information |
Lot Numbers: Lot number 1618030 1630221 1630210 1606342 1624606 1611013 1627740 1618724 1624608 1625037 1611132 1619054 1627111 1619055 1619056 1624607 1618817 1602004 1630111 1619057 1627240 1611046 1611015 1618713 1630211 1611014 1618031 1625004 1619032 1627112 1625003 1624609 1618735 1606408 1611141 1625026 1610954 1611045 1606331 1703344 1611131 1602174 1630013 1618818 1627718 1602186 1618736 1611057 1619033 1610655 1625036 1602152 1610932 1606320 1610931 1610656 1618839 1610953 1611056 1624628 1619043 1610644 1618041 1618714 1624617 1606341 1606330 1618851 1618828 1619021 1610623 1606461 1610909 1624639 1611067 1611119 1618806 1606416 1619010 1606308 1611023 1610942 1606449 1610920 1606438 1610633 1611013 1627740 1618817 1703344 1602185 1610645 1700505 1627252 1630222 1625025 1618142 1611174 1627251 1618850 1606342 1619043 1606342 1606408 1703344 1619043 1606416 1611174 1619022 1606408 1611174 1619022 |
Recalling Firm/ Manufacturer |
Polymer Technology Systems 4600 Anson Blvd Whitestown IN 46075
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Manufacturer Reason for Recall |
A numerical value less than 4% or greater than 13% may be displayed instead of the expected <4% or >13% result, due to a software bug.
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FDA Determined Cause 2 |
Software design |
Action |
A Customer Bulletin dated November 2016 was distributed to customers. |
Quantity in Commerce |
112,648 |
Distribution |
The products were distributed to the following US states: AR, CA, FL, IL, IN, KY, MN, NC, NJ, NY, OH, PA, RI TN, UT, VA, WA, and Puerto Rico.
The products were distributed to the following foreign countries: Australia, Bahamas, Belgium, Bahrain, Bangladesh, Canada, China, Columbia, Czech Republic, England, Egypt, Greece, Spain, India, Indonesia, Haiti, Hong Kong, Italy, Japan, Jordan, Kenya, Lebanon, Mexico, Myanmar, Malaysia, Philippines, Pakistan, South Africa, Nigeria, Poland, Saudi Arabia, Sweden, Turkey, Singapore, Trinidad & Tobago, Slovenia, Vietnam, United Arab Emirates, Uruguay. |
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 = LCP and Original Applicant = BAYER HEALTHCARE, LLC
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