Recall Z-2730-2017
Beckman Coulter Inc · initiated May 15, 2017
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
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.
Codes / lots: Lot No. 72645074, Exp. Date 30 Apr 2018
Reason for recall
The firm identified a negative shift of 5mmol/L for sodium recovery in Synchron Control Level 3 when calibrated with AQUA Cal 1.
FDA-determined cause: Nonconforming Material/Component
Action taken
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)
Details
- Recall number
- Z-2730-2017
- Initiated
- May 15, 2017
- Posted by FDA
- July 13, 2017
- Terminated
- September 9, 2020
- Product code
- JIX – Calibrator, Multi-Analyte Mixture
- 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, Ireland, Italy, Japan, Lebanon, Mexico, Netherlands, Panama, Paraguay, Philippines, Qatar, South…
- Recalling firm
- Beckman Coulter Inc, Brea, CA