FDA Medical Device Recalls (openFDA)
Pointe Scientific, Inc.: Liquid Alkaline Phosphatase Reagent Set; Catalog No. A7516-150-SAM, In vitro diagnostic; for the quantitative determination of alkaline phosphatase in serum, Sold by Pointe Scientific, Inc
- Recall number
- Z-1360-2008
- Recalling firm
- Pointe Scientific, Inc.
- Product
- Liquid Alkaline Phosphatase Reagent Set; Catalog No. A7516-150-SAM, In vitro diagnostic; for the quantitative determination of alkaline phosphatase in serum, Sold by Pointe Scientific, Inc
- Status
- Terminated
- Initiated
- 2008-02-07
- Posted
- 2008-03-27
- Terminated
- 2009-06-12
- Reason
- May be contaminated with microorganisms.
- Root cause
- Other
- Action
- Consignees were notified via recall letter, Urgent Medical Device, dated 2/7/08, to cease using the product, conduct a recall to the user level, destroy product on hand and to notify the firm via the response form of the amount destroyed for replacement purposes. International consignees were notified via email.
- Quantity
- 6
- Distribution
- Worldwide-USA, Canada, Chile, Cyprus, Ecuador, Greece, India, Italy, Jamaica, Korea, Nigeria, Pakistan, Philippines, Poland, Turkey and The West Indies.
- Lot, serial or model codes
- All Lots beginning with 727801; exp. 4/09.
- 510(k) numbers
- ["K973588"]
- PMA numbers
- not on file
- Product code
- CJE
- 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