CLASS II Device recall · Reported 5 Feb 2020 · FDA Enforcement Report
ABS800 Chemistry Analyzer recalled by Mindray DS USA
Mindray DS USA is recalling ABS800 Chemistry Analyzer, distributed in Michigan, Texas. The recall was initiated on 9 Dec 2019 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0921-2020
- FDA event ID
- 84497
- Recalling firm
- Mindray DS USA, Mahwah, NJ
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 9 Dec 2019
- FDA classified
- 30 Jan 2020
- Reported
- 5 Feb 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Test Kits & Diagnostics
Timeline
| 9 Dec 2019 | Recall initiated by company | |
| 30 Jan 2020 | Classified by FDA | +52 days |
| 5 Feb 2020 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
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))
Where it was distributed
The products were distributed to the following US states: MI and TX.
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
Serial Numbers W2-6C000001, W2-6C000002, W2-6C000003, W2-6C000004, W2-6C000005, XP-5B000611T
Where was it sold?
The products were distributed to the following US states: MI and TX.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 84497| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | BA-800M Chemistry Analyzer Part Numbers BA81E-PA00002 recalled | Mindray DS USA | Device Malfunction | MI, TX |
More recalls from Mindray DS USA
All 47| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS III | Passport Series Patient Monitor recalled by Mindray DS USA | Mindray DS USA | Device Malfunction | Nationwide |
| Device | CLASS III | T1 Patient Monitor recalled by Mindray DS USA | Mindray DS USA | Device Malfunction | Nationwide |
| Device | CLASS III | BeneView Series recalled by Mindray DS USA | Mindray DS USA | Device Malfunction | Nationwide |
| Device | CLASS III | cPM Series Patient Monitor recalled by Mindray DS USA | Mindray DS USA | Device Malfunction | Nationwide |
| Device | CLASS III | BeneVision Series Telemetry Monitor recalled by Mindray DS USA | Mindray DS USA | Device Malfunction | Nationwide |
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| Device | CLASS II | MAS Omni Immune PRO Liquid Assayed Integrated Immunoassay recalled | Microgenics | Potency & Assay | Nationwide |
| Device | CLASS II | The ABL90 Flex and ABL90 Flex Plus analyzers are intended recalled | Radiometer Medical ApS | Labeling Errors | Nationwide |