FDA Recall
Terminated
PHADIA Varelisa Cardiolipin IgM Cardiolipin autoantibody immunological test system (IgM class antibodies)
Recall: Z-2285-2012
·
Initiated August 2, 2012
Recall
- Recall Number
- Z-2285-2012
- Event Number
- 62572
- Firm
- Phadia US Inc
- FEI Number
- 3004973408
- Product Code
- MID
- Status
- Terminated
- Root Cause
- Labeling Change Control
- Initiated
- August 2, 2012
- Posted
- August 28, 2012
- Terminated
- December 12, 2012
- Address
- 4169 Commercial Ave, Portage, MI, 49002-9701
Description
PHADIA Varelisa Cardiolipin IgM Cardiolipin autoantibody immunological test system (IgM class antibodies)
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.
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.
Distribution
USA Nationwide.
Quantity
837 kits (96 assays per kit), total of 80,352 individual assays