Recalls / —
—#155844
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.
- FDA product code
- JIX — Calibrator, Multi-Analyte Mixture
- Device class
- Class 2
- Medical specialty
- Clinical Chemistry
- 510(k) numbers
- K071277
- Affected lot / code info
- Lot No. 72645074, Exp. Date 30 Apr 2018
Why it was recalled
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 (FDA determination)
Nonconforming Material/Component
Action the firm took
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)
Recalling firm
- Firm
- Beckman Coulter Inc
- Address
- 250 S Kraemer Blvd, Brea, California 92821-6232
Distribution
- Distribution pattern
- 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 Africa, Taiwan, Thailand, Turkey, United Arab Emirates, & United Kingdom.
Timeline
- Recall initiated
- 2017-05-15
- Posted by FDA
- 2017-07-13
- Terminated
- 2020-09-09
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #155844. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.