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U.S. Department of Health and Human Services

Class 2 Device Recall Bayer brand A1CNow MULTITEST A1C SYSTEM TEST KITS

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  Class 2 Device Recall Bayer brand A1CNow MULTITEST A1C SYSTEM TEST KITS see related information
Date Initiated by Firm August 26, 2013
Date Posted November 02, 2013
Recall Status1 Terminated 3 on January 14, 2014
Recall Number Z-0136-2014
Recall Event ID 66101
510(K)Number K090413  
Product Classification Assay, glycosylated hemoglobin - Product Code LCP
Product Bayer brand A1CNow+ MULTI-TEST A1C SYSTEM TEST KITS (PART NUMBER 3021/08842610); Hemoglobin A1c Monitor; Glycosylated Hemoglobin Assay; Product is manufactured and distributed by
Bayer HealthCare LLC, Sunnyvale, CA


The A1CNow+ test provides quantitative measurement of the percent of glycated hemoglobin (%HbA1c or %A1C) levels in capillary (fingerstick) or venous whole blood samples. The test is for professional use to monitor glycemic control in people with diabetes.
Code Information Lot: 1300733 (US, China);  Lot: 1300712 (Argentina, Uruguay); Lots: 1300711, 130012 (Japan) 
Recalling Firm/
Manufacturer		 Bayer Healthcare Llc
510 Oakmead Pkwy
Sunnyvale CA 94085-4022
For Additional Information Contact Roger Sonnenburg,
408-524-2255 Ext. 290
Manufacturer Reason
for Recall		 Test results from these lots may produce a high-bias reading (by up to 20%) that is outside of limits defined for stability and product accuracy when product is stored at room temperature four (4) to five (5) months after release.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action Bayer Healthcare sent an Urgent Medical Device Recall letter dated August 26, 2013. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to check their inventory for the affected product and quarantine any affected product. Complete the attached Recall Response Form and fax to Bayer Customer Service. Customers were instructed to use the attached letter to notify affected next level customers of the recall. For questions regarding this recall call 408-524-2255, ext 290.
Quantity in Commerce 138 Kits in US (Total 2452)
Distribution Worldwide Distribution - USA (nationwide) and Internationally to China, Argentina, Uruguay, Japan.
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 = LCP and Original Applicant = BAYER HEALTHCARE, LLC
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