Recall Z-2285-2012
Phadia US Inc · initiated August 2, 2012
Class III – products unlikely to cause any adverse health reaction but that violate FDA labeling or manufacturing laws
Product
PHADIA Varelisa Cardiolipin IgM Cardiolipin autoantibody immunological test system (IgM class antibodies)
Codes / lots: Article Number 15696 Lot number #0067
Reason for recall
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.
FDA-determined cause: Labeling Change Control
Action taken
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.
Details
- Recall number
- Z-2285-2012
- Initiated
- August 2, 2012
- Posted by FDA
- August 28, 2012
- Terminated
- December 12, 2012
- Product code
- MID – System, Test, Anticardiolipin Immunological
- Quantity
- 837 kits (96 assays per kit), total of 80,352 individual assays
- Distribution
- USA Nationwide.
- Recalling firm
- Phadia US Inc, Portage, MI