FDA Device recall Z-2488-2023
Beckman Coulter, IVD, REF: OSR61171, IgA, 4 x 14 mL R1, 4 x 11 mL R2
- FDA Device
- Class II
- ongoing
- Published 2023-09-06
On 2023-09-06 the FDA classified a Class II recall of Beckman Coulter, IVD, REF: OSR61171, IgA, 4 x 14 mL R1, 4 x 11 mL R2 by Beckman Coulter, citing lipemic interference failed to meet the performance specification listed within the IFU.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2488-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-07-12 |
| Published | 2023-09-06 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Beckman Coulter |
| Distribution | AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, ND, NE, NJ, NM, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV |
Product
Beckman Coulter, IVD, REF: OSR61171, IgA, 4 x 14 mL R1, 4 x 11 mL R2
Reason
Lipemic interference failed to meet the performance specification listed within the IFU.
Identifiers
| code_info | All Lots/UDI-(01)15099590011574 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2488-2023%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.