Abbott Laboratories MPG
Medical device manufacturer in Abbott Park, IL.
0510(k) clearances
0PMA approvals
4recalls
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-0855-2007 | ARCHITECT STAT Troponin-I Reagent; list numbers 2K41-20 (400 test kit), 2K41-25 (100…False Negative Results : The analytical sensitivity claim of less than or equal to 0.01 ng/mL (ug/L) might… | 03/08/2007Terminated |
| Z-0413-2007 | ARCHITECT i System Assay CD-ROM, in vitro diagnostic analyzer, U.S. Version 21.0; for…The ARCHITECT AUSAB and ARCHITECT Anti-HCV assay parameter default interpretation screens when using… | 01/02/2007Terminated |
| Z-0488-2007 | ARCHITECT LH Reagent, each kit contains bottles of Anti-Beta LH coated Microparticles…The lots of ARCHITECT LH Reagent List 6C25-22, have the potential to generate patient specimen results that… | 11/22/2006Terminated |
| Z-0501-2007 | IMx Sirolimus Reagent Pack; list 5C91-21; 100 test pack containing 1 bottle (9.7 mL)…The sirolimus values may shift higher after storage at 2-8C or after one freeze/thaw cycle of specimens. | 08/11/2006Terminated |