The F.D.A. approved a test from Roche's diagnostics division to detect that mutation.
"We're not letting it deter us," said Dr. James Koziarz, the vice president for research and development for Abbott's diagnostics division.
David P. Holveck, Centocor's executive vice president and president of the diagnostics division, was named president and chief operating officer.
The agency said it took its action after more than six years of prodding Abbott to improve manufacturing processes in its medical diagnostics division to meet federal standards.
The company's diagnostics division had sales of about $2.8 billion a year ago.
He was previously vice president, research and development, of the diagnostics division of Abbot Laboratories Inc., which he joined in 1975.
Another division was added in 1973, called the diagnostics division, which manages all the diagnostics business on a global scale, separate from the international division (Corporate).
The diagnostics division grew by 11 percent in local-currency terms, he said.
Quattromed's activities are divided into three branches: medical diagnostics division, technology development division and life science products division.
The company formerly operated an outpatient rehabilitation, surgery center and diagnostics division.