Pointe Scientific AutoHDL/LDL Cholesterol Calibrator… recallZ-0389-2019 · Medtest Holdings, Inc. · initiated Aug 10, 2018
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Medtest Holdings, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Vials of the autoHDL/LDL Calibrator were shipped without a vial label.
FDA root cause category: Error in labeling
What the company is doing
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.
Recall details
- Recall number
- Z-0389-2019
- Status
- Terminated
- Initiated by the company
- Aug 10, 2018
- Recalling firm
- Medtest Holdings, Inc.
- Quantity
- 22
- Product code
- LBR
- FDA submissions
- K992002
- Distribution
- US Nationwide in the states of CA, FL, GA, MI, and OH.
Product description
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.
Code information (models, lots, serial numbers)
Lot Number 808801-180; UDI: 00811727011411
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Pointe Scientific, Inc. H7545-CALHoriba Instruments Incorporated · Ldl & Vldl Precipitation, Hdl1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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