PHADIA Varelisa Cardiolipin IgM Cardiolipin autoantibody immunological test system (IgM class antibodies)
FDA device recall Z-2285-2012 · posted 2012-08-28 · Terminated
Recall details
- Recalling firm
- Phadia US Inc
- 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.
- 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.
- Root cause
- Labeling Change Control
- Status
- Terminated
- Product code
- MID
- Quantity affected
- 837 kits (96 assays per kit), total of 80,352 individual assays
- Distribution
- USA Nationwide.
- Date initiated
- 2012-08-02
- Date posted
- 2012-08-28
- Date terminated
- 2012-12-12
- Location
- Portage, MI
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| VARELISA CARDIOLIPIN IGM ANTIBODIES, MODELS 15648 & 15696 (K020758) | Pharmacia Deutschland GmbH | 2002-05-02 |