Home › Beckman Coulter, Inc. › IMMAGE
IMMAGE
Beckman Coulter, Inc. · Model A15445 · UDI-DI 15099590265403
JQX
Prescription
10
510(k) clearances
258
Adverse events
4
Recalls
13
Facilities
Description
IMMAGE 800
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2017-06-01 | Becton Dickinson & Co. | Potential unexpected movement of robot arm |
| 2010-05-21 | Beckman Coulter Inc. | Beckman Coulter is initiating a recall of IMMAGE Immunochemistry Systems Buffer 1 (BUF1) due to received reports of increased recovery of control and patient samples using the lots |
| 2006-01-17 | Becton Dickinson & Co. | A operator's manual for a diagnostic test kit is incorrect and may cause inaccurate results for bacterial identification and antibiotic susceptibility in patient samples. |
| 2005-12-01 | Becton Dickinson & Co. | A calibrator for an in vitro diagnostic kit is not standarized correctly and may cause a calibration error when measuring microbiological cultures for turbidity. |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.