Recall Z-2482-2015 ยท JJX Single (Specified) Analyte Controls (Assayed And Unassayed)
Bayer Healthcare, LLC
Contour Next Control Solution for Contour Next Blood Glucose Test System. Liquid quality control solution. Plastic bottle, 2.5mL. Indicated for use with fresh fingertip capillary whole blood samples.
| Date | Aug 29, 2015 (initiated Jun 22, 2015) |
| Status | Terminated |
| Reason | If the control solution bottle is not thoroughly shaken prior to use, the control test result may be higher than the control range and may not be recognized and marked as a control test by the blood glucose meter. Also, the control solution, used as a quality control test in blood glucose meter systems, may read outside the specified range too high or too low. |
| Root cause | Device Design |
| Action | On 6/22/2015, Bayer Healthcare began sending URGENT - MEDICAL DEVICE FIELD CORRECTIVE ACTION notifications to affected Health Care Providers, Pharmacies, and Users. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. Customers are instructed to always check the expiration, not to use and discard of expired control solutions. Also, only CONTOUR NEXT control solution should be used with the CONTOUR NEXT test strips. The control solution bottle should be s |
| Quantity | 5 million bottles of control solution |
| Distribution | Worldwide Distribution -- USA, Australia, Austria, Belgium, Canada, Croatia, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Slovenia, Spain, Sweden, Switzerland, UK, Albania, Azerbaijan, Bulgaria, Czech Republic, Estonia, Hungary, Korea, Latvia, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K111268 | CONTOUR (R) NEXT BLOOD GLUCOSE MONITORING SYSTEM Bayer Healthcare, Mar 6, 2012 |