SeraQuest***CMV IgM TEST SET For the detection of CMV IgM Antibodies 96 Test Set Cat. No. 01-150 Store 2-8 C For In Vitr
FDA device recall Z-0837-2012 · posted 2012-01-23 · Terminated
Recall details
- Recalling firm
- Quest International, Inc.
- Reason for recall
- Quest International recalled their CMV IgM Test kit because the device failed the test run due to lack of activity in the coated wells.
- Action taken
- On September 28, 2010, Quest International, Inc. issued a Memo to its Customers who received the CMV IgM Lot E1700. The memo identified the affected product and stated the problem with the device. The memo asked customers to let the firm know if they had any remaining inventory from the affected lot and the product would be replaced immediately. Questions should be directed to 305-592-6991.
- Root cause
- Storage
- Status
- Terminated
- Product code
- LKQ
- Quantity affected
- 315
- Distribution
- Nationwide Distribution -- Washington and California.
- Date initiated
- 2010-09-28
- Date posted
- 2012-01-23
- Date terminated
- 2012-05-31
- Location
- Doral, FL
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SERAQUEST CMV IGM (K982485) | Quest Intl., Inc. | 1999-01-13 |