Events

Recall of Device Recall Bayer brand A1CNow MULTITEST A1C SYSTEM TEST KITS

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Bayer Healthcare Llc.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    66101
  • Event Risk Class
    Class 2
  • Event Number
    Z-0136-2014
  • Event Initiated Date
    2013-08-26
  • Event Date Posted
    2013-11-02
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-01-14
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=121482
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Assay, glycosylated hemoglobin - Product Code LCP
  • Reason
    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.
  • 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.

Device

Device Recall Bayer brand A1CNow MULTITEST A1C SYSTEM TEST KITS
  • Model / Serial
    Lot: 1300733 (US, China);  Lot: 1300712 (Argentina, Uruguay); Lots: 1300711, 130012 (Japan)
  • Product Classification
    Hematology and Pathology Devices
  • Device Class
    2
  • Implanted device?
    No
  • 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.
  • Manufacturer
    Bayer Healthcare Llc

Manufacturer

Bayer Healthcare Llc
  • Manufacturer Address
    Bayer Healthcare Llc, 510 Oakmead Pkwy, Sunnyvale CA 94085-4022
  • Manufacturer Parent Company (2017)
    Bayer AG
  • Source
    USFDA