PHADIA Varelisa Cardiolipin IgM Cardiolipin autoantibody immunological test system (IgM class antibodies)
This recall has been terminated (originally issued August 28, 2012).
- Company
- Phadia Us Inc
- Recall Initiated
- August 2, 2012
- Posted
- August 28, 2012
- Terminated
- December 12, 2012
- Recall Number
- Z-2285-2012
- Quantity
- 837 kits (96 assays per kit), total of 80,352 individual assays
- Firm Location
- Portage, MI
- Official Source
- View on FDA website ↗
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.
Distribution
USA Nationwide.
Lot / Code Info
Article Number 15696 Lot number #0067
Root 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.
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