Z-1606-2023 Class II Ongoing
FDA device recall Z-1606-2023 was initiated by Beckman Coulter Inc. on April 5, 2023 and is designated Class II. 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. The recall status is ongoing. Affected quantity: 48,633 units in total.
Recall Details
- Product Type
- Devices
- Report Date
- May 24, 2023
- Initiation Date
- April 5, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 48,633 units in total
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.
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,
Code Information
All Lots: UDI-GI: 15099590020187