Z-2730-2017 Class II Terminated
FDA device recall Z-2730-2017 was initiated by Beckman Coulter Inc on May 15, 2017 and is designated Class II. 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. The recall status is terminated (terminated September 9, 2020). Affected quantity: 4444 AQUA CAL Level 1 kits.
Recall Details
- Product Type
- Devices
- Report Date
- July 19, 2017
- Initiation Date
- May 15, 2017
- Termination Date
- September 9, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 4444 AQUA CAL Level 1 kits
Product Description
Reason for Recall
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.