Recall Z-0837-2012 ยท LKQ Antibody Igm,If, Cytomegalovirus Virus
Quest International, Inc.
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 Vitro Diagnostic Use***Contents: 1 96 wells bag with holder, 1 Negative Control*, 1 Positive Control*, 1 Substrate, 1 Stop Solution, 1 Conjugate*, 1 Calibrator 1*, 1 Calibrator 2*, 1 Diluent for Specimen*, 1 Wash Concentrate*, *Contains Sodium Azide Lot No. E1700 Doral, FL 33122 USA
| Date | Jan 23, 2012 (initiated Sep 28, 2010) |
| Status | Terminated |
| Reason | Quest International recalled their CMV IgM Test kit because the device failed the test run due to lack of activity in the coated wells. |
| Root cause | Storage |
| Action | 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. |
| Quantity | 315 |
| Distribution | Nationwide Distribution -- Washington and California. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K982485 | SERAQUEST CMV IGM Quest Intl., Inc., Jan 13, 1999 |