Notice names this product. Beckman Coulter’s REF # D23354 is named in FDA Class II recall Z-2889-2026.
Your particular item is not yet verified. Compare the identifiers and exclusions in the notice before deciding whether it applies.Agency-reported hazard: Analyzers contain incorrect algorithms which may affect antimicrobial susceptibility test results, leading to false susceptibility classifications." Identifying details: UDI: 15099590799250/ V5.03 Panel Update 11. Status: Ongoing.
1. Compare your item
This notice names a product; your particular item is not yet verified. Compare every applicable model, serial, lot, production-date or model-year boundary below.
Product named
REF # D23354
Company / brand
Beckman Coulter
Lot / serial / date codes
UDI: 15099590799250/ V5.03 Panel Update 11
Distribution
US Nationwide distribution including in the states of AK, AL, AR, CA, CO, DE, FL, GA, IA, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NJ, NV, NY, OH, OK, OR, PA, SC, TN, TX, VA, WI, WV, WY.
Agency product description and boundaries
REF # D23354, MicroScan LabPro V5.03 Panel Update 11 DVD Kit (US) on the following instruments: - B1018-280 MicroScan autoSCAN-4 Instrument - B1018-283 MicroScan WalkAway-40 plus Instrument - B1018-284 MicroScan WalkAway-96 plus Instrument - B1018-440 DxM-1040 MicroScan WalkAway Instrument - B1018-496 DxM-1096 MicroScan WalkAway Instrument
Still to verify: match the label on your item with the full official notice, including any exclusions, tables and photos. Some identifiers appear only on the agency website and are absent from this data feed. A missing field does not mean all versions are affected.
If your lot or date falls outside a stated range, this notice has not established that your item is affected. This is not a finding about other recalls or product safety.