Recall Z-0389-2019— Medtest Holdings, Inc.
Class III · Terminated
Class III FDA medical device recall by Medtest Holdings, Inc., initiated 2018-08-10, terminated 2019-12-04. It names one FDA 510(k) clearance: K992002. 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.. Reason: Vials of the autoHDL/LDL Calibrator were shipped without a vial label..
- Recalling firm
- Medtest Holdings, Inc.
- Classification
- Class III
- Status
- Terminated
- Initiated
- 2018-08-10
- Terminated
- 2019-12-04
- Firm location
- Canton, MI, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Reason for recall
Vials of the autoHDL/LDL Calibrator were shipped without a vial label.
Data sourced from openFDA. This site is unofficial and independent of the FDA.