Agency classClass IIOur severity:High FDA (Devices)·Z-0921-2020·Announced 2020-02-05

Mindray ABS800 Chemistry Analyzer Gas Spring Recall

Mindray is recalling six ABS800 Chemistry Analyzers due to a potential gas spring failure that poses 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 involves a risk-of-harm product where injury has not yet been reported, fitting the criteria for a High severity score.

Plain-English summary

Mindray DS USA, Inc. dba Mindray North America is recalling six units of the ABS800 Chemistry Analyzer, Part Number BA81F-PA00001. The recall involves specific gas springs located on the front and rear protective covers of the device.

The recall is being issued because the gas springs on the front and rear protective covers may fail. The source text states there is a low risk of injury to the user resulting from this failure, which may include impact to the arms, hands, or fingers.

The affected units were distributed to Michigan and Texas. The specific serial numbers involved are W2-6C000001, W2-6C000002, W2-6C000003, W2-6C000004, W2-6C000005, and XP-5B000611T. Users should check their equipment serial numbers against this list and contact the manufacturer for instructions.

The recalled product

Product: ABS800 Chemistry Analyzer Part Number BA81F-PA00001, 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
mechanical-failure
Affected units: 6

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 (6)

Serial Numbers W2-6C000001
W2-6C000002
W2-6C000003
W2-6C000004
W2-6C000005
XP-5B000611T

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