FDA Device recall Z-2043-2023
Access Hybritech p2PSA reagent, REF B03704 and REF A49752
- FDA Device
- Class II
- ongoing
- Published 2023-07-05
On 2023-07-05 the FDA classified a Class II recall of Access Hybritech p2PSA reagent, REF B03704 and REF A49752 by Beckman Coulter, citing reagent lot numbers include an insufficient concentration of blocking reagent.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2043-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-05-17 |
| Published | 2023-07-05 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Beckman Coulter |
| Distribution | CA, CO, CT, FL, GA, IL, IN, MA, MI, NC, NE, NJ, NY, OH, SC, TN, TX, UT, WA |
Product
Access Hybritech p2PSA reagent, REF B03704 and REF A49752.
Reason
Reagent lot numbers include an insufficient concentration of blocking reagent.
Identifiers
| code_info | Lot #234320, exp. 7/31/2023, UDI (01)15099590211325(17)230731(11)220731(10)234320; Lot #234134, exp. 6/30/2023, UDI (0…Lot #234320, exp. 7/31/2023, UDI (01)15099590211325(17)230731(11)220731(10)234320; Lot #234134, exp. 6/30/2023, UDI (01)15099590211325(17)230630(11)220630(10)234134; and Lot #234133, exp. 6/30/2023, UDI (01)15099590204112(17)230630(11)220630(10)234133. |
|---|
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-2043-2023%22
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