Device product
Beckman Coulter Bicarbonate, REF: OSR6137, 4x25 mL
Z-1606-2023
Product summary
- Event
- Event 92071
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 48,633 units in total
- Official record key
device-enforcement:Z-1606-2023
Official wording
Reason: There is a potential for a decrease in calibration ODs for Bicarbonate reagent which could result in calibration failures and/or quality control failures.
Code information: All Lots: UDI-GI: 15099590020187
Distribution pattern: 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,
Derived failure modes
-
Unknown
There is a potential for a decrease in calibration ODs for Bicarbonate reagent which could result in calibration failures and/or quality control failures.