FDA Medical Device Recalls (openFDA)
Trek Diagnostic Systems: HARDY DIAGNOSTIC McFarland Standard 0.5; in vitro diagnostic, glass vial, one vial per box
- Recall number
- Z-0669-2009
- Recalling firm
- Trek Diagnostic Systems
- Product
- HARDY DIAGNOSTIC McFarland Standard 0.5; in vitro diagnostic, glass vial, one vial per box
- Status
- Terminated
- Initiated
- 2008-09-22
- Posted
- 2009-01-28
- Terminated
- 2010-07-06
- Reason
- Incorrect result: The absorbance has changed as the standards have aged; the standards' turbidity has become denser. The recalled lot is now reading 0.15 ABS @ 625 nm. TREK'S internal specification and the manufacturer's (Hardy Diagnostics) specification is 0.08 - 0.10 ABS @625 nm. CLSI specifies 0.08 - 0.13 ABS @ 625 nm.
- Root cause
- Nonconforming Material/Component
- Action
- On 9/22/2008 TREK Diagnostic sent a recall notification letter to their customers advising them of the problem with the product. They instructed their customers to inventory their stock for any remaining recall lot and immediately destroy.
- Quantity
- 4 vials
- Distribution
- USA distribution in OH and IL.
- Lot, serial or model codes
- Model Number: Hardy = MSO5; Lot number 08182; Expiration date: 10/28/08
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- JTZ
- Firm FEI
- 1000515493
- Firm city
- Cleveland
- Firm state
- OH
- 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