ABS800 Chemistry Analyzer Part Number BA81F-PA00001 — Class II medical device recall Z-0921-2020
Terminated recall by Mindray DS USA, Inc. dba Mindray North America, reported 2020-02-05, distributed in MI, TX. The gas spring on the front and rear protective cover may fail. There is a low risk of injury to the user resu
| Recall number | Z-0921-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Mindray DS USA, Inc. dba Mindray North America, Mahwah, NJ, United States |
| Recall initiated | 2019-12-09 |
| Classified | 2020-01-30 |
| Reported by FDA | 2020-02-05 |
| Terminated | 2020-09-17 |
| Distributed | MI, TX |
| Quantity | 6 |
| Reason classes | device malfunction |
| Serial numbers | W2-6C000001, W2-6C000002, W2-6C000003, W2-6C000004, W2-6C000005, XP-5B000611T |
| Model numbers | BA81F-PA00001 |
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))
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0921-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.