Utak NR Trace Elements Serum Control, 5 ml, REF 66816. The responsible firm on the label is UTAK LABORATORIES, INC., Valencia, CA. Control for in vitro diagnostics.
FDA Recall Z-2407-2020 · Posted None
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Recalling FirmUtak Laboratories Inc
Recall StatusTerminated
Product CodeJJY
Date Initiated2020-03-20
Date Terminated2020-07-22
Product Quantity1,395 vials
Reason for Recall
The product has an incorrect reference value for cadmium and an incorrect expected range.
Firm Action
The recalling firm issued a recall letter dated 3/19/2020 via email on 3/20/2020 requesting customers to destroy the incorrect IFU and replace it with the revised IFU.
Root Cause
Labeling Change Control
Distribution Pattern
Worldwide Distribution. US nationwide, Canada, Australia, France, Germany, Israel, Italy, New Zealand, Philippines, and United Kingdom.
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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