MicroScan Dried Overnight Gram Negative Panels; Panel type: Neg Breakpoint Combo Type 47, catalog number: B1017-417. Sie
FDA device recall Z-1499-2012 · posted 2012-05-08 · Terminated
Recall details
- Recalling firm
- Siemens Healthcare Diagnostics, Inc.
- Reason for recall
- Three lots were confirmed to not meet performance claims due to random non-biological contamination which is only apparent (precipated) after inoculation of the panels
- Action taken
- Customer Notification letters were sent to all customers of the three MicroScan panels by traceable mail. The letter identified the affected product and asked customers to discard any remaining inventory in addition to contacting customer service for replacement product. The letter also recommended that customers consider the need to review previous test results, conduct patient follow-up, and or repeat tests as needed. Customers were to complete and return the customer reply card to confirm that they received and understood the recall communication.
- Root cause
- Process control
- Status
- Terminated
- Product code
- JWY
- Quantity affected
- 683 boxes (20 panels per box)
- Distribution
- Worldwide Distribution -- US, Turkey, Poland, and Great Britain.
- Date initiated
- 2011-06-16
- Date posted
- 2012-05-08
- Date terminated
- 2012-05-08
- Location
- West Sacramento, CA
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MICRODILUTION PANELS (K862140) | American Micro Scan | 1986-07-16 |