FDA Medical Device Recalls (openFDA)
Wako Chemicals USA, Inc.: NEFA Standard Solution Calibrator, Oleic Acid, 1 mmol/L, 4x10mL bottles per carton, Cat. 276-76491, labeled in part ***For in vitro diagnostic use ***Distributed by: Wako Chemicals, USA, Inc. 1600 Bellwood Road Richmond, VA 23237***
- Recall number
- Z-1071-2007
- Recalling firm
- Wako Chemicals USA, Inc.
- Product
- NEFA Standard Solution Calibrator, Oleic Acid, 1 mmol/L, 4x10mL bottles per carton, Cat. 276-76491, labeled in part ***For in vitro diagnostic use ***Distributed by: Wako Chemicals, USA, Inc. 1600 Bellwood Road Richmond, VA 23237***
- Status
- Terminated
- Initiated
- 2007-03-30
- Posted
- 2007-07-12
- Terminated
- 2007-07-24
- Reason
- Diagnostic reagent for clinical laboratory testing was incorrectly labeled.
- Root cause
- Other
- Action
- The recalling firm notified consignees by letter 03/30/07 and advised of labeling error. Consignees were advised that they could return the product for relabeling or affix correct label enclosed with the notification. Distributors were requested to forward notification to end users. The firm subsequently notified consignees on 04/26/07 by fax that product should be returned for label correction.
- Quantity
- 94 cartons
- Distribution
- Worldwide, including USA, Germany and Canada.
- Lot, serial or model codes
- Lot TQ087, Exp 02/29/08
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- JIT
- Firm FEI
- 3005625991
- Firm city
- Richmond
- Firm state
- VA
- 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