Z-1071-2007

NEFA Standard Solution Calibrator, Oleic Acid, 1 mmol/L, 4x10mL bottles per carton, Cat. 276-76491, labeled...

Name: Z-1071-2007 NEFA Standard Solution Calibrator, Oleic Acid, 1 mmol/L, 4x10mL bottles per carton, Cat. 276-76491, labeled...
Creator: Wako Chemicals USA, Inc.
Published: 2007-03-30
License: https://open.fda.gov/license/

FUJIFILM Healthcare Americas Corporation / initiated 2007-03-30 / Terminated / root cause: labeling and UDI

FDA source

Wako Chemicals USA, Inc. began a recall of NEFA Standard Solution Calibrator, Oleic Acid, 1 mmol/L, 4x10mL bottles per carton, Cat. 276-76491, labeled in part ***For in vitro diagnostic use... on 2007-03-30. The reason FDA records is "Diagnostic reagent for clinical laboratory testing was incorrectly labeled". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1071-2007
Status: Terminated
Initiated: 2007-03-30
Posted: 2007-07-12
Terminated: 2007-07-24
Recalling firm: FUJIFILM Healthcare Americas Corporation
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***
Product code: JIT Calibrator, Secondary
Reason for recall: Diagnostic reagent for clinical laboratory testing was incorrectly labeled.
Root cause tag: labeling and UDI
FDA 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 in commerce: 94 cartons
Distribution: Worldwide, including USA, Germany and Canada.
Product codes and lots: Lot TQ087, Exp 02/29/08

Product code JIT

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)