Beckman Coulter AU5800 analyzer may stop analyzing after database errors
Beckman Coulter is recalling Chemistry Analyzer AU5800 units because leaving the calibration monitor open beyond 15 minutes can trigger database errors that stop the system analyzing.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Rubric level 3 covers risk-of-harm products where injury has not yet been reported: the source states the fault may delay diagnosis and patient treatment, and no injuries are stated.
Plain-English summary
Beckman Coulter Mishima K.K. is recalling the Chemistry Analyzer AU5800, REF B96697, B96698, B23279, B23280 and B23281. About 47 units were distributed across 36 US states and Puerto Rico. The FDA has classified this recall as Class II.
A delay in results may occur. When the clinical chemistry analyzer calibration monitor, on a PC installed with Microsoft SQL Server 2022 Express, is open beyond 15 minutes it may lead to reagent blank and calibration databases not opening, producing "CAL History DB Open Error" and "RB History DB Open Error" messages. The system will stop analyzing and a firm service visit is required to apply a software solution, which may lead to delay in diagnosis and/or patient treatment.
Affected instruments are listed by REF, UDI-DI and serial number in the FDA enforcement record.
Laboratories can identify affected analyzers by the REF numbers above, and may contact Beckman Coulter Mishima K.K. for further information.
The recalled product
- Product
- CHEMISTRY ANALYZER AU5800, REF: B96697, B96698, B23279, B23280, B23281
- Manufacturer
- Beckman Coulter Mishima K.K.
- Affected units
- 47
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 2025061446
- 2025061452
- 2025061454
- 2025061464
- 2025071479
- 2025071488
- 2025081513
- 2025081516
- 2025091536
- 2025091538
- 2025091543
- 2025091559
- 2025091561
- 2025111598
- 2025111602
- 2025111604
- 2025111605
- 2025111606
- 2025121618
- 2025121622
Distribution
Part of a larger recall action
This product is one of 2 recalled by Beckman Coulter Mishima K.K. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
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