|Immucor gets FDA notice to revoke reagent license|
|By Staff and Wire Reports|
|Friday, 26 June 2009 11:12|
June 26 (Reuters) - Blood-testing products maker Immucor Inc (Nasdaq: BLUD) said U.S. health regulators issued a notice of intent to revoke the biologics license for some of the company's blood reagents based on a January 2009 inspection, sending its shares down as much as 30 percent to their four-year low.
The company said the notice was related to two of its blood products -- Reagent Red Blood Cells and Anti-E Blood (Monoclonal) Grouping Reagent product -- that are used to detect antigen and antibody reactions. The two products are mostly used by blood banks.
However, the U.S. Food and Drug Administration (FDA) has not ordered the recall of any of the products, Immucor said in a statement.
The company said it has 10 working days to respond to the FDA's administrative action and 30 days to submit a remediation plan.
Immucor will use the remediation work that is already underway and documented in detail to the FDA, to facilitate its response.
Shares of the company were down $2.62 at $13.47 in early morning trade Friday on Nasdaq. Earlier they touched a four-year low of $11.24.
For the alerts double-click [ID:nWNAB2530] . (Reporting by Anand Basu in Bangalore; Editing by Jarshad Kakkrakandy)