FDA Medical Device Recalls (openFDA)
Medtest Holdings, Inc.: Pointe Scientific Lactate Dehydrogenase (Liquid) Reagent Set Model Number(s): L7572. For the in vitro quantitative kinetic determination of lactate dehydrogenase activity in serum.
- Recall number
- Z-2165-2017
- Recalling firm
- Medtest Holdings, Inc.
- Product
- Pointe Scientific Lactate Dehydrogenase (Liquid) Reagent Set Model Number(s): L7572. For the in vitro quantitative kinetic determination of lactate dehydrogenase activity in serum.
- Status
- Terminated
- Initiated
- 2011-07-08
- Posted
- 2017-05-26
- Terminated
- 2017-06-02
- Reason
- Pointe Scientific Lactate Dehydrogenase (Liquid) Reagent Set stability claim is not being met.
- Root cause
- Nonconforming Material/Component
- Action
- Pointe Scientific issued field communication alerting end users of the corrected stability claim. To date the firm has sent individualized communications to 100% of end users that received the product and posted the notification to the company website.
- Quantity
- 716.146L total
- Distribution
- Nationwide
- Lot, serial or model codes
- L7572 all configurations
- 510(k) numbers
- ["K973589"]
- PMA numbers
- not on file
- Product code
- CFJ
- 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