Z-0685-2020Class II

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

Name: Z-0685-2020 ReliOn FastA1C Test, Software Version Revision D, REF Number 3055
Creator: Polymer Technology Systems
Published: 2016-12-02
License: https://open.fda.gov/license/

Polymer Technology Systems / initiated 2016-12-02 / Terminated / root cause: software

FDA source

Polymer Technology Systems began a recall of ReliOn FastA1C Test, Software Version Revision D, REF Number 3055 on 2016-12-02. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0685-2020
Classification: Class II
Status: Terminated
Initiated: 2016-12-02
Posted: 2019-12-13
Terminated: 2020-07-16
Recalling firm: Polymer Technology Systems
Product: ReliOn FastA1C Test, Software Version Revision D, REF Number 3055
Product code: LCP Assay, Glycosylated Hemoglobin
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.
Root cause tag: software
FDA root cause: Software design
Action: A Customer Bulletin dated November 2016 was distributed to customers.
Quantity in commerce: 20,825
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, Lebanon, Mexico, Myanmar, Malaysia, Philippines, Pakistan, South Africa, Nigeria, Poland, Saudi Arabia, Sweden, Turkey, Singapore, Trinidad & Tobago, Slovenia, Vietnam, United Arab Emirates, Uruguay.
Product codes and lots: Lot Numbers: 1606319 1606405 1606460 1610622 1610910 1611163

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0685-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0682-2020	Class II	Terminated	Voluntary: Firm initiated	2019-12-25	2019-12-13
Z-0683-2020	Class II	Terminated	Voluntary: Firm initiated	2019-12-25	2019-12-13
Z-0684-2020	Class II	Terminated	Voluntary: Firm initiated	2019-12-25	2019-12-13
Z-0685-2020	Class II	Terminated	Voluntary: Firm initiated	2019-12-25	2019-12-13
Z-0686-2020	Class II	Terminated	Voluntary: Firm initiated	2019-12-25	2019-12-13

Product code LCP

K090413Class IIA1cnow+ (10 Test Kit, Professional Use) Model 3024, A1cnow+(20 Test Kit, Professional Use) Model 3021, A1cnow Self ChecBayer Healthcare, LLC / cleared 2009-05-14

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)