Z-1589-2008

VARIANT -thalassemia Short Program Hemoglobin Testing System, Model Number 270-0002 (500 tests), with...

Name: Z-1589-2008 VARIANT -thalassemia Short Program Hemoglobin Testing System, Model Number 270-0002 (500 tests), with...
Creator: Bio-Rad Laboratories Inc
Published: 2008-03-18
License: https://open.fda.gov/license/

Bio-Rad Laboratories Inc. / initiated 2008-03-18 / Terminated

FDA source

Bio-Rad Laboratories Inc began a recall of VARIANT -thalassemia Short Program Hemoglobin Testing System, Model Number 270-0002 (500 tests), with -thalassemia ROM card lot PA 62600, PIN 2700104 on 2008-03-18. The reason FDA records is "Some product ROM cards have an incorrect program loaded and are unable to be updated". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1589-2008
Status: Terminated
Initiated: 2008-03-18
Posted: 2008-09-11
Terminated: 2009-11-10
Recalling firm: Bio-Rad Laboratories Inc.
Product: VARIANT -thalassemia Short Program Hemoglobin Testing System, Model Number 270-0002 (500 tests), with -thalassemia ROM card lot PA 62600, PIN 2700104
Product code: JPD Hemoglobin A2 Quantitation
Reason for recall: Some product ROM cards have an incorrect program loaded and are unable to be updated.
FDA root cause: Mixed-up of materials/components
Action: The firm initiated its recall on March 18, 2008 by issuing a recall notice to customers and subsidiaries via e-mail. Not all VARIANT -Thalassemia Short ROM Cards are affected. Inventory should be examined and quarantine the product subject to this Recall. Contact your regional Bio-Rad office for ROM Card replacement or if you have questions.
Quantity in commerce: 64 kits total
Distribution: Product was distributed to 17 consignees and 7 subsidiaries Worldwide. Distribution included to states of CA, TX, WI, VA, UT, PA, TN, OH, FL, MA, OR, AR, IL, MD, CO, and NY, and countries of UK, Australia, Canada, France, Singapore, New Zealand, Italy.
Product codes and lots: Lot number 70080140 and 70080276

Product code JPD

K924122Class IIVariant Beta-Thalassemia Short ProgramBio-Rad / cleared 1993-03-11

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)