Recall of m2000sp and m1000 Instrument
DATE RECALL INITIATED:
June 12, 2007
PRODUCT / LOT NUMBER:
m2000sp Instrument and m1000 Instrument
List Numbers 9K14-01 and 4J72-01
Not Serial Number Specific)
MANUFACTURER:
TECAN Schweiz AG
Switzerland
DISTRIBUTOR:
Abbott Molecular, Inc.
Des Plaines, IL
REASON:
Abbott has recently identified that spring clips on the Disposable Tips (DiTi) Racks, shipped with or ordered independent of m2000sp or m1000 Instruments, may have sharp protruding corners. Customers are asked to take care to avoid injury from sharp corners on the spring clips when handling the DiTi racks on the m2000sp or m1000 Instrument.
The information in this listing reflects CBER's best efforts to communicate information that has been reported to FDA. Its accuracy and comprehensiveness cannot be guaranteed.