Recall Z-0136-2014 ยท LCP Assay, Glycosylated Hemoglobin
Bayer Healthcare Llc
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 i
| Date | Nov 2, 2013 (initiated Aug 26, 2013) |
| Status | Terminated |
| 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. |
| 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 | 138 Kits in US (Total 2452) |
| Distribution | Worldwide Distribution - USA (nationwide) and Internationally to China, Argentina, Uruguay, Japan. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K090413 | A1CNOW+ (10 TEST KIT, PROFESSIONAL USE) MODEL 3024, A1CNOW+(20 TEST KIT, PROFESSIONAL USE) MODEL 3021, A1CNOW SELF CHEC Bayer Healthcare, LLC, May 14, 2009 |