FDA Medical Device Recalls (openFDA)
Mindray DS USA, Inc. dba Mindray North America: 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))
- Recall number
- Z-0921-2020
- Recalling firm
- Mindray DS USA, Inc. dba Mindray North America
- 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))
- Status
- Terminated
- Initiated
- 2019-12-09
- Posted
- not on file
- Terminated
- 2020-09-17
- Reason
- 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.
- Root cause
- Nonconforming Material/Component
- Action
- The consignee notification was sent certified mail with return receipt verification. The letter identified the affected product, problem and actions to be taken by the Customer/User. Customers were instructed to: Continue to use the system normally and exercise caution when lifting/closing the front and rear cover. Attachment A includes a list of system(s) identified by model and serial number purchased by your company. We recommend that you notify the clients to which you have distributed these systems and advise them to continue normal use with the recommended caution. The gas springs on the systems listed in Attachment A will require replacement and instructions are provided in Attachment B. The parts needed to perform the replacement will be shipped to you within the next several weeks. Type of Action by the Company Mindray will provide replacement gas springs at no cost. Should you require technical assistance while preforming the replacement, please contact Mindrays Technical Support team at 800-288-2121, option 2 (Technical Support), then choose option 3 (IVD Support team).
- Quantity
- 6
- Distribution
- The products were distributed to the following US states: MI and TX.
- Lot, serial or model codes
- Serial Numbers W2-6C000001, W2-6C000002, W2-6C000003, W2-6C000004, W2-6C000005, XP-5B000611T
- 510(k) numbers
- ["K160370"]
- PMA numbers
- not on file
- Product code
- JGS
- Firm FEI
- 2221819
- Firm city
- Mahwah
- Firm state
- NJ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28