Recall Z-0322-06 ยท JQP Calculator/Data Processing Module, For Clinical Use
Olympus America, Inc
OLA 2500 Olympus Lab Automation Systems to include the following models (all serial numbers): S2 Full Size, S3 Full Size, Standard Full Size and High Speed Full Size (Aliquoter) manufactured by Olympus Life and Material Science Europa GmbH, Germany and distributed by Olympus America, Inc., 3131 W. Royal Ln., Irving, TX 75063.
| Date | Dec 23, 2005 (initiated Nov 18, 2005) |
| Status | Terminated |
| Reason | Lab Automation System may dilute samples with water. |
| Root cause | Other |
| Action | Firm initiated recall on 11/18/05 via letter to all direct accounts. |
| Quantity | 6 total units. |
| Distribution | Nationwide; Distribution was made to laboratories and blood centers located in CA, CO, GA, NC, and OH. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.