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U.S. Department of Health and Human Services

Class 2 Device Recall A1CNow SELF CHECK

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 Class 2 Device Recall A1CNow SELF CHECKsee related information
Date Initiated by FirmDecember 02, 2016
Create DateDecember 13, 2019
Recall Status1 Terminated 3 on July 16, 2020
Recall NumberZ-0683-2020
Recall Event ID 84231
510(K)NumberK090413 
Product Classification Assay, glycosylated hemoglobin - Product Code LCP
ProductA1CNow SELF CHECK (European), Software Version Revision D, REF Numbers 3054, 3062
Code Information Lot Numbers: 1610622 1618153 
FEI Number 3002698769
Recalling Firm/
Manufacturer		 Polymer Technology Systems
4600 Anson Blvd
Whitestown IN 46075
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.
FDA Determined
Cause 2		Software design
ActionA Customer Bulletin dated November 2016 was distributed to customers.
Quantity in Commerce500
DistributionThe 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 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 = LCP
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