Mindray BS-200 Chemistry Analyzer Recalled for Inaccurate Clinical Results
Mindray is recalling three BS-200 Chemistry Analyzers because clinical chemistry results may be inaccurate. The units were distributed in North Carolina and Texas.
What this means for you
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: The recall involves a medical device where inaccurate clinical chemistry results could lead to incorrect patient care, representing a risk-of-harm product where specific injury reports are not detailed in the source text.
Plain-English summary
Mindray DS USA, Inc. d.b.a. Mindray North America is recalling three units of the BS-200 Chemistry Analyzer, a device designed for clinical laboratory use. The recall was initiated because an issue was identified where clinical chemistry results may be inaccurate.
The affected units are identified by part number BA20E-PA00003 and serial numbers WN-28103978F, WN-28103976F, and WN-28103977F. These devices were distributed in the states of North Carolina and Texas.
Clinical laboratories should contact Mindray DS USA, Inc. d.b.a. Mindray North America for instructions on how to return the affected units. Users should verify their equipment against the provided serial numbers to determine if they are affected by this recall.
The recalled product
- Product
- BS-200 Chemistry Analyzer Designed for clinical laboratory use.
- Hazard
- Affected units
- 3
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 (4)
- Part number BA20E-PA00003
- Serial Numbers: WN-28103978F
- WN-28103976F
- and WN-28103977F.
Distribution
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