Recalls / —

—#25729

Product

Access Progesterone Assay, Part number 33550.

FDA product code

JLS — Radioimmunoassay, Progesterone

Device class

Class 1

Medical specialty

Clinical Chemistry

510(k) numbers

K955769

Affected lot / code info

All Lots.

Why it was recalled

Primary tube sampling issue may cause false low results.

Root cause (FDA determination)

Other

Action the firm took

Recall letters were sent to customers on 12/6/2002 informing them to not process the sample directly from the primary collection tubes but to pour off a bit into a separate tube. Labs are to incorporate this into their Standard Operating Procedures until the firm can identify another resolution to the problem.

Recalling firm

Firm

Beckman Coulter Inc

Address

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

Distribution

Distribution pattern

USA and Canada.

Timeline

Recall initiated

2002-12-06

Posted by FDA

2003-01-30

Terminated

2003-07-26

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #25729. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.