Recall Z-0216-2009 ยท JJX Single (Specified) Analyte Controls (Assayed And Unassayed)
Abbott Laboratories
Architect LH MasterCheck (List 6C25-05). An in-vitro diagnostic, consisting of 4 - 2 mL vials of LH MasterCheck, Levels 0, 1, 2 and 3. Manufactured for Abbott Laboratories, Abbott Park, IL 60064. ARCHITECT LH MasterCheck is intended for use in the verification of sensitivity, calibration linearity, and reportable range of the LH assay on the Abbott ARCHITECT i System.
| Date | Nov 13, 2008 (initiated Sep 5, 2008) |
| Status | Terminated |
| Reason | The values listed in the Architect LH MasterCheck, Lot 82520 data sheet are incorrect. When MasterChecks do not perform as intended, the integrity of the system cannot be verified and patient results would not be generated. Other commercially available materials are available to customers in order to meet CLIA requirements. |
| Root cause | Error in labeling |
| Action | A Product Correction, Immediate Action Required letter and Customer Reply Form dated 9/5/08 were sent to all Architect LH MasterChecks (List Number 6C25-05) customers who received Lot 82520M. Customers were informed that the values listed in the Architect LH MasterCheck Lot 82520 data sheet are incorrect. Customers were requested to check their inventory for the affected lot, and if any kits were found, to substitute the values printed on the data sheet with the values supplied in the letter. In addition, Customers were requested to keep a copy of the letter on file and to complete the Cust |
| Quantity | 30 kits |
| Distribution | Nationwide Distribution including Arizona, California, Florida, Illinois, Kansas, Louisiana, Massachusetts, Missouri, Montana, New York, Ohio, Pennsylvania, South Carolina, Texas, Utah and Virginia. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K984323 | ARCHITECT LH MASTERCHECK, MODEL NUMBER 6C25-05 Bio-Rad, Dec 15, 1998 |