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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 84231

5 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
December 02, 2016
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Polymer Technology Systems

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

5 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 5

A1CNow+ Systems (professional use product), Software Version Revision D, REF Numbers US: 3021, 3024; EU: 3037, 3038, 3057, 3058

Z-0682-2020
Recall number
Z-0682-2020
Initiated
December 02, 2016
Classification
Class II
Status
Terminated
Quantity
112,648

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
software bug

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software design

Compare all device evidence states

Inspect official wording and provenance

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.

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

Distribution pattern

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.

device · product 2 of 5

A1CNow SELF CHECK (European), Software Version Revision D, REF Numbers 3054, 3062

Z-0683-2020
Recall number
Z-0683-2020
Initiated
December 02, 2016
Classification
Class II
Status
Terminated
Quantity
500

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
software bug

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software design

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

Lot Numbers: 1610622 1618153

Distribution pattern

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.

device · product 3 of 5

Walgreens At-Home A1C Test Kit, Software Version Revision D, REF Number 3056

Z-0684-2020
Recall number
Z-0684-2020
Initiated
December 02, 2016
Classification
Class II
Status
Terminated
Quantity
15,118

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
software bug

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software design

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

Lot Numbers: 1606405 1610622 1610910

Distribution pattern

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.

device · product 4 of 5

ReliOn FastA1C Test, Software Version Revision D, REF Number 3055

Z-0685-2020
Recall number
Z-0685-2020
Initiated
December 02, 2016
Classification
Class II
Status
Terminated
Quantity
20,825

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
software bug

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software design

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

Lot Numbers: 1606319 1606405 1606460 1610622 1610910 1611163

Distribution pattern

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.

device · product 5 of 5

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

Z-0686-2020
Recall number
Z-0686-2020
Initiated
December 02, 2016
Classification
Class II
Status
Terminated
Quantity
8285

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
software bug

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software design

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

Lot Numbers: 1606319 1606405 1606460 1610622 1610910 1611163 1618153

Distribution pattern

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.

Field note

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