Recall Z-0686-2020

Polymer Technology Systems · initiated December 2, 2016

Class II Terminated

Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature

Product

CVS Health At Home A1C Test Kit, Software Version Revision D, REF Number 3059

Codes / lots: Lot Numbers: 1606319 1606405 1606460 1610622 1610910 1611163 1618153

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: Software design

Action taken

A Customer Bulletin dated November 2016 was distributed to customers.

Details

Recall number
Z-0686-2020
Initiated
December 2, 2016
Terminated
July 16, 2020
Product code
LCP – Assay, Glycosylated Hemoglobin
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, England, Egypt, Greece, Spain, India, Indonesia, Haiti, Hong Kong, Italy, Japan, Jordan, Kenya…
Recalling firm
Polymer Technology Systems, Whitestown, IN

Official FDA recall record

Other products in the same recall event

RecallProductInitiated
Z-0682-2020 Class IIA1CNow+ Systems (professional use product), Software Version Revision D, REF Numbers US:…A numerical value less than 4% or greater than 13% may be displayed instead of the expected <4% or >13%… 12/02/2016Terminated
Z-0683-2020 Class IIA1CNow SELF CHECK (European), Software Version Revision D, REF Numbers 3054, 3062A numerical value less than 4% or greater than 13% may be displayed instead of the expected <4% or >13%… 12/02/2016Terminated
Z-0684-2020 Class IIWalgreens At-Home A1C Test Kit, Software Version Revision D, REF Number 3056A numerical value less than 4% or greater than 13% may be displayed instead of the expected <4% or >13%… 12/02/2016Terminated
Z-0685-2020 Class IIReliOn FastA1C Test, Software Version Revision D, REF Number 3055A numerical value less than 4% or greater than 13% may be displayed instead of the expected <4% or >13%… 12/02/2016Terminated