Test kit used in the assessment of breast cancer patients for whom Herceptin therapy is being considered. BioGenex brand
FDA device recall Z-0606-06 · posted 2006-03-15 · Terminated
Recall details
- Recalling firm
- Biogenex Laboratories
- Reason for recall
- Products produce granular staining in immunostained tissue sections, which may lead to misdiagnosis due to false positive result.
- Action taken
- On 2/9/06, the firm issued letters via UPS to all of its consignees, informing them of the affected products and providing instructions on the recall.
- Root cause
- Other
- Status
- Terminated
- Product code
- MVC
- Quantity affected
- 14 units
- Distribution
- Nationwide. Italy, and United Kingdom. The product was released for distribution to 21 consignees nationwide to CA, FL, GA, IA, IL, NC, NJ, NY, TX, VT, WA, and WI. One VA account: VA Medical Center, G
- Date initiated
- 2006-02-09
- Date posted
- 2006-03-15
- Date terminated
- 2006-08-23
- Location
- San Ramon, CA
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