DiaSorin Anti-Cardiolipin IgA ELISA kit for the detection in human serum or plasma of antoantibodies specific for Cardiolipin IgA. Catalog No.: 7800. Manufactured for DiaSorin Inc., 1951 Northwestern Avenue, Stillwater, MN 55082-0285
This recall has been terminated (originally issued March 18, 2005).
- Company
- Diasorin Inc.
- Recall Initiated
- January 23, 2004
- Posted
- March 18, 2005
- Terminated
- July 22, 2006
- Recall Number
- Z-0632-05
- Quantity
- 16 kits
- Firm Location
- Stillwater, MN
- Official Source
- View on FDA website ↗
Reason for Recall
DiaSorin Anti-Cardiolipin IgA kit's positive control is out of acceptable limits.
Distribution
GA, NY & KS
Lot / Code Info
catalog # 7800, lot # 039229, expiration date 12/23/04
Root Cause
Other
Action Taken
Customers were notified via a letter which described the product and the problem. Recommended to destroy all affected kits and stated that the kits will be replaced.
More recalls by Diasorin Inc.
DiaSorin LIAISON Q.S.E.T. Device Plus, REF 319060; intended for use in the preparation of human stoo...
Dec 12, 2024
DiaSorin LIAISON HSV-2 Type Specific IgG, REF 310620
Jan 25, 2024
LIAISON 1-84 PTH Assay - Product Usage: is an in vitro chemiluminescent immunoassay (CLIA) intended...
Nov 23, 2020
Parvovirus B19 IgG EIA kit
Part No. V519IGUS
Jul 17, 2020