FDA Medical Device Recalls (openFDA)
Pointe Scientific, Inc.: Pointe Scientific Direct Bilirubin Reagent Set, Pointe Scientific Inc., Canton, MI., Catalog # HB936-1250.
- Recall number
- Z-1014-2010
- Recalling firm
- Pointe Scientific, Inc.
- Product
- Pointe Scientific Direct Bilirubin Reagent Set, Pointe Scientific Inc., Canton, MI., Catalog # HB936-1250.
- Status
- Terminated
- Initiated
- 2009-07-29
- Posted
- 2010-03-05
- Terminated
- 2010-12-06
- Reason
- R2 reagent component may fail because it may contain R1 reagent. The reagent was rendered inoperative and would not pass the required quality control (calibration and quality control testing) before beginning running the bilirubin assay.
- Root cause
- Error in labeling
- Action
- Consignee was notified by letter dated 7/29/2009 and instructed to identify and notify them at once of this product recall. Product is to be returned or destroyed. Customers with questions should contact the firm directly.
- Quantity
- 2
- Distribution
- California.
- Lot, serial or model codes
- Lot 817103-337.
- 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