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

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

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

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).

Distribution

As reported by FDA

MI, TX