--- title: "Beckman Coulter Mishima K.K. Recalls: Agency-Reported Status and History (Oct 1, 2026) | Is It on Recall" description: "Search Beckman Coulter Mishima K.K. recall records, lots, firms and dates. Reported status can be incomplete; use the linked agency notice for current instructions." url: https://isitonrecall.com/brand/beckman-coulter-mishima-k-k/ updated: 2026-10-01 site: "Is It on Recall" language: en --- [Home](https://isitonrecall.com/) / Brand archive # Beckman Coulter Mishima K.K. recall records **4** reported ongoing 6 records in this archive. Latest source date Jan 30, 2026. FDA enforcement status can lag behind the recall lifecycle. An empty search or a reported termination is not a personal product-safety determination. Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/). ## Records and reported status Jan 30, 2026 FDA device enforcement ### [DxC 700 AU, REF: B86444, B86446](https://isitonrecall.com/recall/fda-device-z-1552-2026-dxc-700-au-ref-b86444-b86446/) A delay in results may occur. When clinical chemistry analyzer calibration monitor with PC installed with Microsoft SQL Server 2022 Express is open beyond15 minutes may lead to: Reagent Blank and calibration databases not opening errors: CAL History DB Open... Class II Reported ongoing Distribution: US Nationwide distribution including in the states of NE, WA, PA, CA, AZ, NC, TX, NV, CT, AL, NJ, TN, MT, ID, GA, SC, OH, KS, WI, HI, FL, VA, MI, NH, ME, NY, OR, LA, PR, MN, IL,... [Official source for DxC 700 AU, REF: B86444, B86446](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1552-2026%22) Jan 30, 2026 FDA device enforcement ### [CHEMISTRY ANALYZER AU5800, REF: B96697, B96698, B23279, B23280, B23281](https://isitonrecall.com/recall/fda-device-z-1553-2026-chemistry-analyzer-au5800-ref-b96697-b96698-b23279-b23280-b23281/) A delay in results may occur. When clinical chemistry analyzer calibration monitor with PC installed with Microsoft SQL Server 2022 Express is open beyond15 minutes may lead to: Reagent Blank and calibration databases not opening errors: CAL History DB Open... Class II Reported ongoing Distribution: US Nationwide distribution including in the states of NE, WA, PA, CA, AZ, NC, TX, NV, CT, AL, NJ, TN, MT, ID, GA, SC, OH, KS, WI, HI, FL, VA, MI, NH, ME, NY, OR, LA, PR, MN, IL,... [Official source for CHEMISTRY ANALYZER AU5800, REF: B96697, B96698, B23279, B23280, B23281](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1553-2026%22) Apr 30, 2025 FDA device enforcement ### [Sample probe sucks a sample dispensed into a tube or cup and discharges the appropriate amount into a cuvette. Lot 178713114 - 179433670](https://isitonrecall.com/recall/fda-device-z-1907-2025-sample-probe-sucks-a-sample-dispensed-into-a-tube-or-cup-and-discharges-the-appropriate-amount-into/) A manufacturing defect in the sample probe (S probe). The corners of the tip of the defective S probe are rounded and chamfered, which can prevent the proper formation of the "air layer" required for normal dispensing. The air layer is the air space that se... Class II Reported completed Distribution: Worldwide Distribution: US (nationwide) including states of: CA, PA, VA, TX, NJ, FL, IN, MA, NY, NC, OH, LA, AZ, MO, WA, GA, UT, KY, AL, CO, IL, NE, OK, NV, SC, TN, MD, OR, AR, ... [Official source for Sample probe sucks a sample dispensed into a tube or cup and discharges the appropriate amount in...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1907-2025%22) Apr 30, 2025 FDA device enforcement ### [Sample probe sucks a sample dispensed into a tube or cup and discharges the appropriate amount into a cuvette. Lot 178713114 - 179433670](https://isitonrecall.com/recall/fda-device-z-1908-2025-sample-probe-sucks-a-sample-dispensed-into-a-tube-or-cup-and-discharges-the-appropriate-amount-into/) Sample probes with defective probe tips, when used with clinical chemistry analyzers, may lead to a lower concentration being dispensed, which may not be detectable by QC checks, which could lead to the reporting of false low test results (Max 34% error at ... Class II Reported completed Distribution: Worldwide Distribution: US (nationwide) including states of: CA, PA, VA, TX, NJ, FL, IN, MA, NY, NC, OH, LA, AZ, MO, WA, GA, UT, KY, AL, CO, IL, NE, OK, NV, SC, TN, MD, OR, AR, ... [Official source for Sample probe sucks a sample dispensed into a tube or cup and discharges the appropriate amount in...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1908-2025%22) Jul 10, 2024 FDA device enforcement ### [DxC 500 AU Clinical Chemistry Analyzer, REF C63520 is an automated chemistry analyzer that measures analytes in samples, in combination with appropriate reagents, calibrators, q...](https://isitonrecall.com/recall/fda-device-z-2691-2024-dxc-500-au-clinical-chemistry-analyzer-ref-c63520-is-an-automated-chemistry-analyzer-that-measures-a/) Due to a software issues, after the instrument processes 250 racks cumulatively, any subsequent racks with samples requiring rerun/reflex will be held in the Sample Handler's Buffer area and and error code "9000" will be reported. This issue may cause a del... Class II Reported ongoing Distribution: Worldwide - U.S. Nationwide distribution in the states of AL, CA, GA, HI, IL, MI, MN, MS, NE, NY, OR, PA and SC. The countries of Lebanon, South Africa. [Official source for DxC 500 AU Clinical Chemistry Analyzer, REF C63520 is an automated chemistry analyzer that measur...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2691-2024%22) Jun 5, 2024 FDA device enforcement ### [DxC 500 AU Clinical Chemistry Analyzer, REF C63520 is an automated chemistry analyzer that measures analytes in samples, in combination with appropriate reagents, calibrators, q...](https://isitonrecall.com/recall/fda-device-z-2455-2024-dxc-500-au-clinical-chemistry-analyzer-ref-c63520-is-an-automated-chemistry-analyzer-that-measures-a/) There are two software bug issues with the analyzer. Issue 1: When a dedicated rack is reserved for calibration, after a calibration test has been placed and completed, the same rack may be used to place both a patient order and a calibration order. When a ... Class II Reported ongoing Distribution: Worldwide - U.S. Nationwide distribution in the states of AL, CA, GA, HI, IL, MI, MN, MS, NE, NY, OR, PA and SC. The countries of Lebanon, and South Africa. [Official source for DxC 500 AU Clinical Chemistry Analyzer, REF C63520 is an automated chemistry analyzer that measur...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2455-2024%22) ## Reasons in these listed records - A delay in results may occur. When clinical chemistry analyzer calibration monitor with PC installed with Microsoft SQL Server 2022 Express is open beyond15 minutes may lead to: Reagent Blank and calibration databases not opening errors: CAL History DB Open Error.., RB History... - A delay in results may occur. When clinical chemistry analyzer calibration monitor with PC installed with Microsoft SQL Server 2022 Express is open beyond15 minutes may lead to: Reagent Blank and calibration databases not opening errors: CAL History DB Open Error.., RB History... - A manufacturing defect in the sample probe (S probe). The corners of the tip of the defective S probe are rounded and chamfered, which can prevent the proper formation of the "air layer" required for normal dispensing. The air layer is the air space that separates the cleaning... - Sample probes with defective probe tips, when used with clinical chemistry analyzers, may lead to a lower concentration being dispensed, which may not be detectable by QC checks, which could lead to the reporting of false low test results (Max 34% error at 1.0 microliters and ... These examples come from this result page and are not a ranking of every recall reason. ## Checking Beckman Coulter Mishima K.K. ### Is there a recall on beckman coulter mishima k.k. right now? This archive contains 6 records, including 4 with agency-reported ongoing status. The status field can be incomplete or stale. Open the current official notice and match your exact product. ### How do I check my package or product? Compare the product, firm and lot, date, model or serial identifiers with the notice. [Use the label-check guide](https://isitonrecall.com/guides/read-lot-codes/) if you need help locating an identifier. ### Does a matching name mean every item is included? A name is a search match. The agency notice sets the affected products and identifiers. Do not assume that every item with the same name or brand belongs to the recall. ### What if the search finds no matching record? This search has source and keyword limits. Missing records or a missing lot code do not establish that a product is unaffected. [Check source coverage](https://isitonrecall.com/sources/) and the agency's current notices. ### Where can I find older records? Use [monthly archives](https://isitonrecall.com/archives/) or the local search. The initial import covers records dated from October 2021 where available; each source's actual first and latest dates appear on the coverage page. ## Keep checking [Search Beckman Coulter Mishima K.K.](https://isitonrecall.com/check/?q=Beckman%20Coulter%20Mishima%20K.K.) [Browse related products](https://isitonrecall.com/products/) [Review source dates](https://isitonrecall.com/sources/)