Bayer brand A1CNow+ MULTI-TEST A1C SYSTEM TEST KITS (PART… recallZ-0136-2014 · Bayer Healthcare Llc · initiated Aug 26, 2013
Class II Terminated All recalls posted in November 2013
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Bayer Healthcare Llc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Nonconforming Material/Component
What the company is doing
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.
Recall details
- Recall number
- Z-0136-2014
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Aug 26, 2013
- Posted by the FDA
- Nov 2, 2013
- Recalling firm
- Bayer Healthcare Llc
- Quantity
- 138 Kits in US (Total 2452)
- Product code
- LCP
- FDA submissions
- K090413
- Distribution
- Worldwide Distribution - USA (nationwide) and Internationally to China, Argentina, Uruguay, Japan.
Product description
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.
Code information (models, lots, serial numbers)
Lot: 1300733 (US, China); Lot: 1300712 (Argentina, Uruguay); Lots: 1300711, 130012 (Japan)
Other devices under the same FDA submission
4 devices cleared under K090413 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- A1CNow®+ Multi-UseTest System (20 count) 3021Polymer Technology Systems, Inc. · ASSAY, GLYCOSYLATED HEMOGLOBIN1 recall11 reports
- A1CNow® Self Check Test System 3070Polymer Technology Systems, Inc. · ASSAY, GLYCOSYLATED HEMOGLOBIN6 reports
- Well at Walgreens 3056Walgreen CO. · Assay, Glycosylated Hemoglobin1 report
- ReliOn™ 2CT A1C Meter 3055Wal-Mart Stores, Inc. · Assay, Glycosylated Hemoglobin1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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