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Diazyme
DIAZYME LABORATORIES, INC. · Model 10-0148 · UDI-DI 00817089021433
1
510(k) clearances
1
Adverse events
12
Recalls
1
Facilities
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2010-08-20 | DiaDexus, Inc | Product fails stability tests prior to expiration date. |
| 2010-03-15 | DiaDexus, Inc | The reason for the recall is that Real Time Stability Test program showed the kit lot failed stability prior to expiration, affecting samples with results> 500 ng/ml. Results up t |
| 2009-10-29 | DiaDexus, Inc | Inaccurate results-- some samples may return with falsely elevated results potentially as a result of an interfering substance. Some patients may be subjected to additional lifest |
| 2009-10-29 | DiaDexus, Inc | Inaccurate results-- some samples may return with falsely elevated results potentially as a result of an interfering substance. Some patients may be subjected to additional lifest |
| 2009-10-29 | DiaDexus, Inc | Inaccurate results-- some samples may return with falsely elevated results potentially as a result of an interfering substance. Some patients may be subjected to additional lifest |
| 2009-10-29 | DiaDexus, Inc | Inaccurate results-- some samples may return with falsely elevated results potentially as a result of an interfering substance. Some patients may be subjected to additional lifes |
| 2009-10-29 | DiaDexus, Inc | Inaccurate results-- some samples may return with falsely elevated results potentially as a result of an interfering substance. Some patients may be subjected to additional lifest |
| 2009-10-29 | DiaDexus, Inc | Inaccurate results-- some samples may return with falsely elevated results potentially as a result of an interfering substance. Some patients may be subjected to additional lifest |
| 2009-02-09 | DiaDexus, Inc | Premature Expiration-- the product is projected to fall short of expected shelf life, and may result in inaccurate results. |
| 2008-11-04 | DiaDexus, Inc | Storage equipment failure at distributor site due to Hurricane Ike caused product to experience a temperature variation and go out of range. The integrity of the product could not |
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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.