Beckman Coulter Bicarbonate, REF: OSR6137, 4x25 mL
Reported: May 24, 2023 Initiated: April 5, 2023 #Z-1606-2023
Product Description
Beckman Coulter Bicarbonate, REF: OSR6137, 4x25 mL
Reason for Recall
There is a potential for a decrease in calibration ODs for Bicarbonate reagent which could result in calibration failures and/or quality control failures.
Details
- Recalling Firm
- Beckman Coulter Inc.
- Units Affected
- 48,633 units in total
- Distribution
- 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,
- Location
- Brea, CA
Frequently Asked Questions
What product was recalled? ▼
Beckman Coulter Bicarbonate, REF: OSR6137, 4x25 mL. Recalled by Beckman Coulter Inc.. Units affected: 48,633 units in total.
Why was this product recalled? ▼
There is a potential for a decrease in calibration ODs for Bicarbonate reagent which could result in calibration failures and/or quality control failures.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 24, 2023. Severity: Moderate. Recall number: Z-1606-2023.
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