Recalls / —

—#25915

Product

AcT 5 diff Cap Pierce Hematology Analyzer 864.5220 Automated differential cell counter

510(k) numbers

K003677

Affected lot / code info

Not applicaable.

Why it was recalled

Failure to cycle properly ammong samples.

Root cause (FDA determination)

Other

Action the firm took

Customers were sent a letter dated January 20, 2003 that describes this situation and provides modified operating instructions to prevent the occurence.

Recalling firm

Firm

Beckman Coulter Inc

Address

200 South Kraemer Blvd W, 337, Brea, California 92822

Distribution

Distribution pattern

US and Canada

Timeline

Recall initiated

2003-01-20

Posted by FDA

2003-02-25

Terminated

2003-07-26

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #25915. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.