BA-800M Chemistry Analyzer Part Numbers BA81E-PA00002 and... (Mindray DS USA, Inc. dba Mindray North America) – the gas spring on the front and rear ... (2019)
Class II: 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 product may cause injury under certain conditions.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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))
Brand
Mindray DS USA, Inc. dba Mindray North America
Lot Codes / Batch Numbers
Serial Numbers: W1-6C000006, W1-71000007, W1-73000009, W1-73000010, XP-68000687T, W1-71000008, W1-85000011
Products Sold
Serial Numbers: W1-6C000006, W1-71000007, W1-73000009, W1-73000010, XP-68000687T, W1-71000008, W1-85000011
Mindray DS USA, Inc. dba Mindray North America is recalling BA-800M Chemistry Analyzer Part Numbers BA81E-PA00002 and BA81E-PA00003, Containing Gas spring YQ-8/ due to The gas spring on the front and rear protective cover may fail. There is a low risk of injury to the user resulting from failure of the gas spring. I. This is a Class I recall, indicating a high risk of serious health consequences or death. Based on FDA medical device enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The gas spring on the front and rear protective cover may fail. There is a low risk of injury to the user resulting from failure of the gas spring. Injury may include impact to the arms, hands or fingers.
Recommended Action
Per FDA guidance
Healthcare providers and patients should stop using the device and contact the manufacturer for further instructions. Report problems to FDA MedWatch.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
MI, TX
Page updated: Mar 8, 2026