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Terminated

Aquarius CSF1R/RPS14 (5q32-q33) Probe Red, Model LPH540-A Analyte specific reagent.

FDA Recall Z-1202-2019 · Posted None

Recalling FirmCytocell Ltd.
Recall StatusTerminated
Product CodeMVU
Date Initiated2019-03-15
Date Terminated2020-10-13
Product Quantity19

Reason for Recall

There is an error in the chromomap included in the labeling for the product.

Firm Action

Urgent Medical Device Recall notification letters dated 3/15/19 were sent to customers.

Root Cause

Labeling Change Control

Distribution Pattern

The products were distributed to the following US states: IL, TN.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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