FDA Medical Device Recalls (openFDA)
Pointe Scientific, Inc.: Pointe Scientific Direct Bilirubin Reagent Set, Pointe Scientific Inc., Canton, MI. The device intended use is a clinical chemistry reagent for the in vitro, quantitative determination of direct bilirubin in serum on Hitachi analyzers.
- Recall number
- Z-1202-2009
- Recalling firm
- Pointe Scientific, Inc.
- Product
- Pointe Scientific Direct Bilirubin Reagent Set, Pointe Scientific Inc., Canton, MI. The device intended use is a clinical chemistry reagent for the in vitro, quantitative determination of direct bilirubin in serum on Hitachi analyzers.
- Status
- Terminated
- Initiated
- 2009-02-02
- Posted
- 2009-04-17
- Terminated
- 2010-10-13
- Reason
- The product performance fails due to precipitation of the R2 component.
- Root cause
- Process control
- Action
- Consignees were notified by "Urgent: Medical Device Recall" letter dated February 2, 2009 and mailed on February 6, 2009, and instructed to conduct the recall to the retail level if they had further distributed the product, to destroy any stocks on hand, and to complete and return the "Recall Return Response Form" via mail, e-mail, or fax (734-483-1592) to Point Scientific, Inc. Direct questions to the firm's Technical Support Department at 1-800-757-5313 or 1-734-487-8300.
- Quantity
- 24 kits
- Distribution
- Worldwide Distribution -- USA, Chile and Mexico.
- Lot, serial or model codes
- HB936-120, Lot Number: 731801, exp. 11/2011 and HB936-294, Lot Number: 817103, exp. 5/2012.
- 510(k) numbers
- ["K040391"]
- PMA numbers
- not on file
- Product code
- CIG
- Firm FEI
- 1827821
- Firm city
- Canton
- Firm state
- MI
- 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