Recall Z-0686-2020 ยท LCP Assay, Glycosylated Hemoglobin
Polymer Technology Systems
CVS Health At Home A1C Test Kit, Software Version Revision D, REF Number 3059
| Date | Dec 2, 2016 |
| Status | Terminated |
| Reason | 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. |
| Root cause | Software design |
| Action | A Customer Bulletin dated November 2016 was distributed to customers. |
| Quantity | 8285 |
| 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, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K090413 | A1CNOW+ (10 TEST KIT, PROFESSIONAL USE) MODEL 3024, A1CNOW+(20 TEST KIT, PROFESSIONAL USE) MODEL 3021, A1CNOW SELF CHEC Bayer Healthcare, LLC, May 14, 2009 |