Beckman Coulter Mishima K.K. 2026-03-18 Health serious FDA
Health · FDA · Recall #FDA-Z-1553-2026
CHEMISTRY ANALYZER AU5800, REF: B96697, B96698, B23279, B23280, B23281 Recall
Issued March 18, 2026 · Beckman Coulter Mishima K.K.
In March 2026, Beckman Coulter Mishima K.K. recalled the CHEMISTRY ANALYZER AU5800, REF: B96697, B96698, B23279, B23280, B23281, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
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 DB Open Error..; system will stop analyzing, firm service must visit to apply software solution; may lead to delay in diagnosis and/or patient treatment
What you should do
- 1 Stop using CHEMISTRY ANALYZER AU5800, REF: B96697, B96698, B23279, B23280, B23281 right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Beckman Coulter Mishima K.K. to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- Beckman Coulter Mishima K.K.
- Category
- Health
- Recall date
- March 18, 2026
- Units affected
- Not reported
- Sold at
- 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
- Recall number
- FDA-Z-1553-2026
- Made in
- Japan
- Issuing agency
- FDA
In context
- Beckman Coulter Mishima K.K. has 3 recalls in our database.
- We're tracking 3,576 Health recalls in our database.
- This is the 356th Health recall we've logged in 2026.