Recall Z-1606-2023 ยท KHS Enzymatic, Carbon-Dioxide
Beckman Coulter Inc.
Beckman Coulter Bicarbonate, REF: OSR6137, 4x25 mL
| Date | May 18, 2023 (initiated Apr 5, 2023) |
| Status | Open, Classified |
| 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. |
| Root cause | Under Investigation by firm |
| Action | On April 5, 2023, Beckman Coulter (BEC) issued a "URGENT MEDICAL DEVICE RECALL" Notification via mail and/or E-Mail. In addition, to informing consignees about the recalled product, BEC asked consignees to take the following actions: 1. Safely dispose of the Bicarbonate lot numbers that are specifically described in Table A. 2. If replacement or re-imbursement of the above lots is required, customers are directed to contact their local Beckman Coulter representative for replacement and re-imbursement. 3. Customers are advised to implement the adjusted Calibration OD range using the instruct |
| Quantity | 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K131546 | AU BICARBONATE REAGENT Beckman Coulter Ireland, Inc., Oct 9, 2013 |