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.
FDA Recall Z-0389-2019 · Posted None
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Recalling FirmMedtest Holdings, Inc.
Recall StatusTerminated
Product CodeLBR
Date Initiated2018-08-10
Date Terminated2019-12-04
Product Quantity22
Reason for Recall
Vials of the autoHDL/LDL Calibrator were shipped without a vial label.
Firm 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.
Root Cause
Error in labeling
Distribution Pattern
US Nationwide in the states of CA, FL, GA, MI, and OH.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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