FDA Medical Device Recalls (openFDA)
Bio-Rad Laboratories Inc: VARIANT -thalassemia Short Program Hemoglobin Testing System, Model Number 270-0002 (500 tests), with -thalassemia ROM card lot PA 62600, PIN 2700104
- Recall number
- Z-1589-2008
- 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
- Status
- Terminated
- Initiated
- 2008-03-18
- Posted
- 2008-09-11
- Terminated
- 2009-11-10
- Reason
- Some product ROM cards have an incorrect program loaded and are unable to be updated.
- 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
- 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.
- Lot, serial or model codes
- Lot number 70080140 and 70080276
- 510(k) numbers
- ["K924122"]
- PMA numbers
- not on file
- Product code
- JPD
- Firm FEI
- 2915274
- Firm city
- Hercules
- Firm state
- CA
- 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