Recall Z-0921-2020 ยท JGS Electrode, Ion Specific, Sodium
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))
| Date | Dec 9, 2019 |
| Status | Terminated |
| 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 |
| Quantity | 6 |
| Distribution | The products were distributed to the following US states: MI and TX. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K160370 | BS-800M/ ABS800/BA-800M ISE KIT, BS-800M Chemistry Analyzer, BA-800M Chemistry Analyzer, ABS800 Chemistry Analyzer Shenzhen Mindray Bio-Medical Electronics Co., Ltd., Jun 9, 2016 |