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Terminated

Pneumonia (33 Targets) Control Panel, unassayed quality control material, containing: Positive Control 1 - Semi-Quantitative Bacteria Positive Control 2 - Viruses and Atypical Bacteria

FDA Recall Z-0844-2022 · Posted None

Recalling FirmMicrobiologics Inc
Recall StatusTerminated
Product CodeOHQ
Date Initiated2022-03-03
Date Terminated2024-01-16
Product Quantity13 units

Reason for Recall

Shelf-life for the 8244 Pneumonia (33 Targets) Control Panel determined to be 6 months instead of 18 months.

Firm Action

Microbiologics notified customers on 03/03/2022 via letter titled "Urgent Medical Device Recall Re: 8244 Pneumonia (33 Targets) Control Panel". Instructions included to review lab procedures to understand how the information affects usage, discard expired product, complete the response form provided, return the response form to [email protected], and keep the letter for consignees' records. Questions or concerns can be directed to the Recall Support team at 320.229.7073 or [email protected].

Root Cause

Incorrect or no expiration date

Distribution Pattern

US distribution to Alabama, Georgia, Illinois, Montana, Pennsylvania, Tennessee, Texas, and Wisconsin

Official Source

View FDA Recall →

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

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