FDA Device

Access Progesterone Assay, Part number 33550.

Hazard

Primary tube sampling issue may cause false low results.

What You Should Do

Remedy

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.

Products

Access Progesterone Assay, Part number 33550.
Brand
Beckman Coulter Inc
UPC
All Lots.

Units Affected

6,655