Recall Z-0488-2007 ยท CEP Radioimmunoassay, Luteinizing Hormone
Abbott Laboratories MPG
ARCHITECT LH Reagent, each kit contains bottles of Anti-Beta LH coated Microparticles and bottles of Anti-Alpha LH acridinium-labeled Conjugate; list numbers 6C25-22 (4 x 100 tests), 6C25-27(1 x 100 tests), and 6C25-30 (4 x 500 tests); Abbott Laboratories, Abbott Park, IL 60064-3500
| Date | Jan 11, 2007 (initiated Nov 22, 2006) |
| Status | Terminated |
| Reason | The lots of ARCHITECT LH Reagent List 6C25-22, have the potential to generate patient specimen results that are elevated. Correlation studies have demonstrated an upward shift in slope for patient results of approximately 13% on average when compared to other currently available reagent lots and an average bias from patient specimens of 13% to 17% has been observed. |
| Root cause | Other |
| Action | Abbott initiated a field correction recall by letter dated 11/22/06 to all customers receiving the affected reagent. The accounts were informed of the elevated patient results with the affected lots of reagents. The accounts were requested to assess the inventory for the affected lots of reagents, discontinue use of the lots and destroy the remaining inventory of the lots, recording the number of kits on the customer reply form and faxing it to Abbott by 12/6/06, indicating that the letter was received and understood. Credit will be issued for the number of kits destroyed, as indicated on the |
| Quantity | 2,960 kits |
| Distribution | Worldwide distribution including U.S.A., Puerto Rico, Canada, Mexico, Venezuela, Colombia, Chile, Uruguay, Argentina, Brazil, Dominican Republic, Germany, Japan, Singapore, Hong Kong, Taiwan, Thailand, South Korea, Australia, New Zealand and Panama. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.