Recall Z-0440-2011 ยท JJY Multi-Analyte Controls, All Kinds (Assayed)
Biosite Inc Dba Innovacon Inc.
Cholestech LDX Multi-Analyte Controls, Level 1 & 2, 3 vial set, Catalog Number 12-713. Assayed quality control material for use with the Cholestech LDX System.
| Date | Nov 22, 2010 (initiated Oct 6, 2010) |
| Status | Terminated |
| Reason | The recall was initiated because results were being reported as being out of range. Firm is reassigning ranges for HDL cholesterol in product. |
| Root cause | Pending |
| Action | All customers were notified and given instructions, requirements, and expectations for their role in the Correction activities using the Notice of Correction with attached Returned Verification Forms which were supplied via fax, email or direct mail beginning on October 6, 2010. Customers are to share the information provided in the Notice with their laboratory staff and retain the letter as part of their laboratory Quality System documentation. If any affected product had been further distributed to another laboratory, then a copy of the letter should be provided to them. Customers are to |
| Quantity | 750 kits |
| Distribution | Worldwide Distribution -- USA, Australia, Canada, Great Britain, India, Italy, Mexico, Norway, Puerto Rico, South Korea, Spain, Switzerland, and Trinidad & Tobago. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K913687 | CHEM-CHEX Streck Laboratories, Inc., Sep 19, 1991 |