Recall Z-0494-03 ยท JLS Radioimmunoassay, Progesterone
Beckman Coulter Inc
Access Progesterone Assay, Part number 33550.
| Date | Jan 30, 2003 (initiated Dec 6, 2002) |
| Status | Terminated |
| Reason | Primary tube sampling issue may cause false low results. |
| Root cause | Other |
| Action | 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. |
| Quantity | 6,655 |
| Distribution | USA and Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K955769 | ACCESS PROGESTERONE ASSAY Bio-Rad Laboratories, Inc., Feb 5, 1996 |