FDA-Device2023-05-24Class II
Beckman Coulter Bicarbonate, REF: OSR6137, 4x25 mL
Beckman Coulter Inc.
Hazard
There is a potential for a decrease in calibration ODs for Bicarbonate reagent which could result in calibration failures and/or quality control failures.
Sold states
Worldwide Distribution: US (nationwide): AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY, Guam, & Puerto Rico and OUS (foreign) countries of: Brazil ,Canada, Mexico, Panama, Taiwan,
Affected count
48,633 units in total
Manufactured in
250 S Kraemer Blvd, N/A, Brea, CA, United States
Products
Beckman Coulter Bicarbonate, REF: OSR6137, 4x25 mL
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1606-2023Don't want to check this manually?
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