FDA Recall Terminated

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: Z-0921-2020 · Initiated December 9, 2019

Recall

Recall Number: Z-0921-2020
Event Number: 84497
Firm: Mindray DS USA, Inc. dba Mindray North America
FEI Number: 2221819
Product Code: JGS
Status: Terminated
Root Cause: Nonconforming Material/Component
Initiated: December 9, 2019
Terminated: September 17, 2020
Address: 800 Macarthur Blvd, Mahwah, NJ, 07430-2001

Description

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.

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).

Distribution

The products were distributed to the following US states: MI and TX.

Quantity