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Recall Observatory FDA recall evidence

Device product

Beckman Coulter Bicarbonate, REF: OSR6237, 4x50 mL

Z-1607-2023

April 05, 2023

Class II

Product summary

Firm
Beckman Coulter Inc.
Event
Event 92071
Status
Ongoing
Classification
Class II
Quantity
48,633 units in total
Official record key
device-enforcement:Z-1607-2023

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: 15099590010348

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

    reason.no_named_rule · v1.0.0

    There is a potential for a decrease in calibration ODs for Bicarbonate reagent which could result in calibration failures and/or quality control failures.