Recall Z-2285-2012 ยท MID System, Test, Anticardiolipin Immunological
Phadia US Inc
PHADIA Varelisa Cardiolipin IgM Cardiolipin autoantibody immunological test system (IgM class antibodies)
| Date | Aug 28, 2012 (initiated Aug 2, 2012) |
| Status | Terminated |
| Reason | Customers were not following the labeled assay procedure. This was due to a letter issued to them in 2004 from Phadia GmbH, which indicated that customers could omit the pre-wash step. The omission of the pre-wash step, when combined with a change in material source in kit lot #0067, caused elevated results. |
| Root cause | Labeling Change Control |
| Action | On 8/2/2012 an URGENT PRODUCT CORRECTION INFORMATION FOR PHADIA VARELISA CARDIOLIPIN IGM, Article Number 15696 letter was sent to all consignees the received the Direction for Use modification letter in 2004. |
| Quantity | 837 kits (96 assays per kit), total of 80,352 individual assays |
| Distribution | USA Nationwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K020758 | VARELISA CARDIOLIPIN IGM ANTIBODIES, MODELS 15648 & 15696 Pharmacia Deutschland GmbH, May 2, 2002 |