Recall Z-2730-2017 ยท JIX Calibrator, Multi-Analyte Mixture
Beckman Coulter Inc
Beckman Coulter Synchron AQUA CAL Level 1, Part No. 471288 Product Usage: Used for the system calibration of Na, K, Cl, Urea N, Urea, Glucose Creatine, Ca, CO2, and P in UniCel DxC Systems.
| Date | Jul 13, 2017 (initiated May 15, 2017) |
| Status | Terminated |
| Reason | The firm identified a negative shift of 5mmol/L for sodium recovery in Synchron Control Level 3 when calibrated with AQUA Cal 1. |
| Root cause | Nonconforming Material/Component |
| Action | Recall notices will be sent via mail or email to customers the week of 05/15/2017. Customers are instructed to discard the affected calibrator and request a replacement. Call Client Services at (800) 526-3821 (US only) |
| Quantity | 4444 AQUA CAL Level 1 kits |
| Distribution | US Nationwide Distribution in the states of AL, AR, AK, CA, CO, DE, FL, GA, ID, IL, IN, IO, KS, KY, LA, MA, MD, MS, MI, ME, MO, NE, NV, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SC, TN, TX, VA, WA, WV, WI, and Puerto Rico Brunei, Canada, China, Czech Republic, France, Guatemala, Hong Kong, India, Ire |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K071277 | SYNCHRON LX20 CLINICAL SYSTEMS, CREATININE TEST SYSTEMS Beckman Coulter, Inc., Jun 1, 2007 |