CLASS III Device recall · Reported 14 Nov 2018 · FDA Enforcement Report
Pointe Scientific AutoHDL/LDL Cholesterol Calibrator recalled
Medtest Holdings is recalling Pointe Scientific AutoHDL/LDL Cholesterol Calibrator, distributed nationwide in the US. The recall was initiated on 10 Aug 2018 and the FDA has classified it as Class III.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0389-2019
- FDA event ID
- 81160
- Recalling firm
- Medtest Holdings, Canton, MI
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 10 Aug 2018
- FDA classified
- 5 Nov 2018
- Reported
- 14 Nov 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Telephone
- Reason category
- Other Reasons
- Device type
- Test Kits & Diagnostics
Timeline
| 10 Aug 2018 | Recall initiated by company | |
| 5 Nov 2018 | Classified by FDA | +87 days |
| 14 Nov 2018 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Vials of the autoHDL/LDL Calibrator were shipped without a vial label.
Product as listed by the FDA
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.
Where it was distributed
US Nationwide in the states of CA, FL, GA, MI, and OH.
Questions about this recall
Is Pointe Scientific AutoHDL/LDL Cholesterol Calibrator recalled?
Yes. Medtest Holdings recalled Pointe Scientific AutoHDL/LDL Cholesterol Calibrator on 10 Aug 2018. The recall is Class III and its status is Terminated. Recall number Z-0389-2019.
Why was it recalled?
Vials of the autoHDL/LDL Calibrator were shipped without a vial label.
Which lots are affected?
Lot Number 808801-180; UDI: 00811727011411
Where was it sold?
US Nationwide in the states of CA, FL, GA, MI, and OH.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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