Z-0322-06

OLA 2500 Olympus Lab Automation Systems to include the following models (all serial numbers): S2 Full Size...

Name: Z-0322-06 OLA 2500 Olympus Lab Automation Systems to include the following models (all serial numbers): S2 Full Size...
Creator: Olympus America, Inc
Published: 2005-11-18
License: https://open.fda.gov/license/

OLYMPUS Corporation of the Americas / initiated 2005-11-18 / Terminated

FDA source

Olympus America, Inc began a recall of 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... on 2005-11-18. The reason FDA records is "Lab Automation System may dilute samples with water". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0322-06
Status: Terminated
Initiated: 2005-11-18
Posted: 2005-12-23
Terminated: 2008-03-10
Recalling firm: OLYMPUS Corporation of the Americas
Product: 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.
Product code: JQP Calculator/Data Processing Module, For Clinical Use
Reason for recall: Lab Automation System may dilute samples with water.
FDA root cause: Other
Action: Firm initiated recall on 11/18/05 via letter to all direct accounts.
Quantity in commerce: 6 total units.
Distribution: Nationwide; Distribution was made to laboratories and blood centers located in CA, CO, GA, NC, and OH.
Product codes and lots: Serial Numbers: 93, 96, 112, 114, 1014 and 1054. Serial numbers correspond to units currently in distribution.

Product code JQP

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)