FDA Medical Device Recalls (openFDA)
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.
- Recall number
- Z-0322-06
- Recalling firm
- Olympus America, Inc
- 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.
- Status
- Terminated
- Initiated
- 2005-11-18
- Posted
- 2005-12-23
- Terminated
- 2008-03-10
- 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.
- Lot, serial or model codes
- Serial Numbers: 93, 96, 112, 114, 1014 and 1054. Serial numbers correspond to units currently in distribution.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- JQP
- Firm FEI
- 3002406108
- Firm city
- Irving
- Firm state
- TX
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28