The Recall Desk
HighFDA (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.

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 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
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 →

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