Bayer brand A1CNow+ MULTI-TEST A1C SYSTEM TEST KITS (PART NUMBER 3021/08842610); Hemoglobin A1c Monitor; Glycosylated He
FDA device recall Z-0136-2014 · posted 2013-11-02 · Terminated
Recall details
- Recalling firm
- Bayer Healthcare Llc
- 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.
- Action taken
- 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.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- LCP
- Quantity affected
- 138 Kits in US (Total 2452)
- Distribution
- Worldwide Distribution - USA (nationwide) and Internationally to China, Argentina, Uruguay, Japan.
- Date initiated
- 2013-08-26
- Date posted
- 2013-11-02
- Date terminated
- 2014-01-14
- Location
- Sunnyvale, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| A1CNOW+ (10 TEST KIT, PROFESSIONAL USE) MODEL 3024, A1CNOW+(20 TEST KIT, PROFESSIONAL USE) MODEL 3021, A1CNOW SELF CHEC (K090413) | Bayer Healthcare, LLC | 2009-05-14 |