Adverse-event reports (MAUDE)
Read this first: MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line shows reporting volume for the average device in the same FDA product code — a reporting baseline, not a risk measure.
No adverse-event reports are linked to this device.
Recall history
| Initiated | Recall # | Class | Status | Reason | Quantity | Link basis |
|---|---|---|---|---|---|---|
| 2019-08-09 | Z-0282-2020 | Class II | Terminated | The assigned value for Rheumatoid Factor over recovers against the reference material RF serum, 1st British standard from NIBSC. Ref = 64/002. The calibrator values have been adjusted to re-align to the reference material.Distribution: US Nationwide distribution in the states of WV, ME, NJ, CA, and Puerto Rico. | 17 kits | clearance family |
Regulatory clearances
Predicate lineage
K972220
Cited as predicate by: K162263
Lineage each submission cites, walked transitively (indented = the cited device's own predicates). Extracted from public 510(k) summary text — heuristic, and includes reference devices mentioned alongside true predicates.
Manufacturer compliance record
| Date | Type | Outcome | Facility | Citations |
|---|---|---|---|---|
| 2026-02-26 | NAI | No action indicated | Siemens Healthcare Diagnostics Products Ltd. | 0 |
| 2024-05-24 | NAI | No action indicated | Siemens Healthcare Diagnostics, Inc. | 0 |
| 2024-05-24 | NAI | No action indicated | Siemens Healthcare Diagnostics, Inc. | 0 |
| 2022-03-30 | NAI | No action indicated | Siemens Healthcare Diagnostics, Inc. | 0 |
| 2022-03-30 | NAI | No action indicated | Siemens Healthcare Diagnostics, Inc. | 0 |
| 2022-03-08 | VAI | Voluntary action indicated | Siemens Healthcare Diagnostics, Inc. | 2 |
| 2022-03-08 | VAI | Voluntary action indicated | Siemens Healthcare Diagnostics, Inc. | 2 |
| 2021-08-19 | NAI | No action indicated | Siemens Healthcare Diagnostics Inc | 0 |
| 2021-08-19 | NAI | No action indicated | Siemens Healthcare Diagnostics Inc | 0 |
| 2021-03-12 | NAI | No action indicated | Siemens Healthcare Diagnostics, Inc. | 0 |
| 2021-03-12 | NAI | No action indicated | Siemens Healthcare Diagnostics, Inc. | 0 |
| 2019-03-18 | NAI | No action indicated | Siemens Healthcare Diagnostics Inc. | 0 |
| 2018-05-24 | NAI | No action indicated | Siemens Healthcare Diagnostics Manufacturing Limited | 0 |
| 2018-03-02 | VAI | Voluntary action indicated | Siemens Healthcare Diagnostics, Inc. | 4 |
| 2018-03-02 | VAI | Voluntary action indicated | Siemens Healthcare Diagnostics, Inc. | 4 |
| 2017-11-29 | NAI | No action indicated | Siemens Healthcare Diagnostics, Inc. | 0 |
| 2017-11-29 | NAI | No action indicated | Siemens Healthcare Diagnostics, Inc. | 0 |
| 2017-11-09 | NAI | No action indicated | Siemens Healthcare Diagnostics Inc | 0 |
| 2017-09-26 | NAI | No action indicated | Siemens Healthcare Diagnostics Inc. | 0 |
| 2017-08-25 | NAI | No action indicated | Siemens Healthcare Diagnostics Inc. | 0 |
| 2012-06-29 | WL | Warning Letter | Siemens Healthcare Diagnostics, Inc. | — |
| 2012-06-29 | WL | Warning Letter | Siemens Healthcare Diagnostics, Inc. | — |
| 2012-05-29 | WL | Warning Letter | Siemens Healthcare Diagnostics, Inc. | — |
| 2012-05-29 | WL | Warning Letter | Siemens Healthcare Diagnostics, Inc. | — |
| 2012-05-10 | WL | Warning Letter | Siemens Healthcare Diagnostics, Inc. | — |
| 2012-05-10 | WL | Warning Letter | Siemens Healthcare Diagnostics, Inc. | — |
Similar devices
- AIM RF TEST GERMAINE LABORATORIES, INC
- ARCHITECT ABBOTT IRELAND
- ARCHITECT ABBOTT LABORATORIES
- ARCHITECT ABBOTT LABORATORIES
- ASI RF Direct Slide Test ARLINGTON SCIENTIFIC, INC.
- ASI RF Direct Slide Test ARLINGTON SCIENTIFIC, INC.
- ASI RF Direct Slide Test ARLINGTON SCIENTIFIC, INC.
- ASI RF Direct Slide Test ARLINGTON SCIENTIFIC, INC.
- ASI RF Direct Slide Test Control Set ARLINGTON SCIENTIFIC, INC.
- ASI RF Direct Slide Tests for Export ARLINGTON SCIENTIFIC, INC.
- AU Beckman Coulter, Inc.
- AccuDiag ™ Diagnostic Automation, Inc.
Select up to two to place side-by-side with this device.