FDA Medical Device Recalls (openFDA)
Medtest Holdings, Inc.: Pointe Scientific AutoHDL/LDL Cholesterol Calibrator, Catalog Number H7545-CAL - Product Usage: For the calibration of Pointe Scientific s autoHDL and autoLDL Cholesterol Reagent Set in serum or plasma. For in vitro diagnostic use only.
- Recall number
- Z-0389-2019
- Recalling firm
- Medtest Holdings, Inc.
- Product
- Pointe Scientific AutoHDL/LDL Cholesterol Calibrator, Catalog Number H7545-CAL - Product Usage: For the calibration of Pointe Scientific s autoHDL and autoLDL Cholesterol Reagent Set in serum or plasma. For in vitro diagnostic use only.
- Status
- Terminated
- Initiated
- 2018-08-10
- Posted
- not on file
- Terminated
- 2019-12-04
- Reason
- Vials of the autoHDL/LDL Calibrator were shipped without a vial label.
- Root cause
- Error in labeling
- Action
- Notification letters dated 8/14/18 were sent to customers. Customers were also contacted via telephone on 8/10/18. Additional letters containing labels dated 8/17/18 were sent to customers.
- Quantity
- 22
- Distribution
- US Nationwide in the states of CA, FL, GA, MI, and OH.
- Lot, serial or model codes
- Lot Number 808801-180; UDI: 00811727011411
- 510(k) numbers
- ["K992002"]
- PMA numbers
- not on file
- Product code
- LBR
- 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