Z-0136-2014Class II

Bayer brand A1CNow+ MULTI-TEST A1C SYSTEM TEST KITS (PART NUMBER 3021/08842610); Hemoglobin A1c Monitor...

Name: Z-0136-2014 Bayer brand A1CNow+ MULTI-TEST A1C SYSTEM TEST KITS (PART NUMBER 3021/08842610); Hemoglobin A1c Monitor...
Creator: Bayer Healthcare Llc
Published: 2013-08-26
License: https://open.fda.gov/license/

Medrad, Inc. / initiated 2013-08-26 / Terminated / root cause: manufacturing process

FDA source

Bayer Healthcare Llc began a recall of Bayer brand A1CNow+ MULTI-TEST A1C SYSTEM TEST KITS (PART NUMBER 3021/08842610); Hemoglobin A1c Monitor; Glycosylated Hemoglobin Assay; Product is manufactured... on 2013-08-26. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0136-2014
Classification: Class II
Status: Terminated
Initiated: 2013-08-26
Posted: 2013-11-02
Terminated: 2014-01-14
Recalling firm: Medrad, Inc.
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.
Product code: LCP Assay, Glycosylated Hemoglobin
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.
Root cause tag: manufacturing process
FDA root cause: 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.
Product codes and lots: Lot: 1300733 (US, China); Lot: 1300712 (Argentina, Uruguay); Lots: 1300711, 130012 (Japan)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0136-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0136-2014	Class II	Terminated	Voluntary: Firm initiated	2013-11-13	2013-11-01

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)