diaDexus PLAC Test ELISA Kit; Manufactured and distributed by diaDexus , Inc., South San Francisco, CA; Model Part Numbe
FDA device recall Z-0429-2011 · posted 2010-11-22 · Terminated
Recall details
- Recalling firm
- DiaDexus, Inc
- Reason for recall
- 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 to 500 ng/ml exhibit passing stability results and are not impacted by this issue.
- Action taken
- DiaDexus notified all customers by phone, including distributor's customers, beginning on March 15, 2010. Customers were told to re-test samples that were tested from 2/1/2010 through 2/28/2010 which have values above 500 ng/ml with a new lot of product. For questions regarding this recall call (650) 246-6477.
- Root cause
- Other
- Status
- Terminated
- Product code
- NOE
- Quantity affected
- 239 kits
- Distribution
- Nationwide Distribution - US including NJ, OH, KS, IN, FL, CA, UT, OK, PA, WA and MI.
- Date initiated
- 2010-03-15
- Date posted
- 2010-11-22
- Date terminated
- 2011-01-11
- Location
- South San Francisco, CA
Monitor recalls programmatically
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