Agency classClass IIOur severity:High FDA (Devices)·Z-0920-2020·Announced 2020-02-05

Mindray BA-800M Chemistry Analyzer Recalled for Gas Spring Failure Risk

Mindray is recalling seven BA-800M Chemistry Analyzers because a gas spring on the protective cover may fail, posing a low risk of impact injury to users.

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: The recall is classified as FDA Class II and involves a risk-of-harm product (impact injury) where no specific injuries have been reported yet, fitting the 'High' severity criteria.

Plain-English summary

Mindray DS USA, Inc. dba Mindray North America is recalling seven units of the BA-800M Chemistry Analyzer. The recall involves specific part numbers (BA81E-PA00002 and BA81E-PA00003) that contain gas springs identified as YQ-8/18-90-272-180N (front) and YQ6/15-84-235(B-B)-80N (rear). The affected units were distributed to Michigan and Texas.

The recall is being conducted because the gas spring on the front and rear protective cover may fail. The FDA classifies this as a Class II recall. The source text states there is a low risk of injury to the user resulting from the failure, which may include impact to the arms, hands, or fingers.

Affected serial numbers include W1-6C000006, W1-71000007, W1-73000009, W1-73000010, XP-68000687T, W1-71000008, and W1-85000011. Users should contact the recalling firm for instructions on how to address the defect.

The recalled product

Product: BA-800M Chemistry Analyzer Part Numbers BA81E-PA00002 and BA81E-PA00003, Containing Gas spring YQ-8/18-90-272-180N (Material Code M6T-010001--- (front spring)) and Gas spring YQ6/15-84-235(B-B)-80N (033-000090-00 (rear spring))
Manufacturer: Mindray DS USA, Inc. dba Mindray North America
Category: Medical Device — Laboratory Equipment
Hazard: impact-injury
Affected units: 7

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 (7)

Serial Numbers: W1-6C000006
W1-71000007
W1-73000009
W1-73000010
XP-68000687T
W1-71000008
W1-85000011

Distribution

Distributed in 2 states:

Part of a larger recall action

This product is one of 2 recalled by Mindray DS USA, Inc. dba Mindray North America 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 →

Same manufacturer · Mindray DS USA, Inc. dba Mindray North America

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Same hazard · impact injury