diaDexus Inc. PLAC Test Reagent Kit, Turbidimetric Immunoassay for the Quantitative Determination of Lp-PLA2 in Human Pl
FDA device recall Z-1204-2009 · posted 2009-04-01 · Terminated
Recall details
- Recalling firm
- DiaDexus, Inc
- Reason for recall
- 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 be assured.
- Action taken
- The firm and its distributor contacted the consignees via phone on 11/04/08. The firm informed them of the issue and inquired about the products' status. An Urgent: Device Recall letter was issued on 11/04/08 via FedEx. The letter requested that use of the kit be immediately discontinued and returned promptly. A phone call was made to follow up requesting return of the product.
- Root cause
- Other
- Status
- Terminated
- Product code
- NOE
- Quantity affected
- 27 units
- Distribution
- Nationwide Distribution
- Date initiated
- 2008-11-04
- Date posted
- 2009-04-01
- Date terminated
- 2009-12-21
- Location
- South San Francisco, CA
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