DxC 500 AU Clinical Chemistry Analyzer, REF C63520 is an automated chemistry analyzer… Recall
Issued August 7, 2024 · Beckman Coulter Mishima K.K.
In August 2024, Beckman Coulter Mishima K.K. recalled the DxC 500 AU Clinical Chemistry Analyzer, REF C63520 is an automated chemistry analyzer…, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
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 patient sample and a non-barcoded calibrator tube is processed on the rack, the calibration result will be reported as a patient result. Issue 2: calibration with expired calibrator. They both may cause erroneous patient results, but the probability of serious adverse health consequences or death is unlikely.
What you should do
- 1 Stop using DxC 500 AU Clinical Chemistry Analyzer, REF C63520 is an automated chemistry analyzer… 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.
Recall details
- Brand
- Beckman Coulter Mishima K.K.
- Category
- Health
- Recall date
- August 7, 2024
- Units affected
- Not reported
- Sold at
- 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, a
- Recall number
- FDA-Z-2455-2024
- 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 737th Health recall we've logged in 2024.