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Terminated

Remel Blood Agar/MacConkey Agar Bi-Plate, REF: R02049

FDA Recall Z-0769-2021 · Posted None

Recalling FirmRemel Inc
Recall StatusTerminated
Product CodeJSI
Date Initiated2020-12-10
Date Terminated2023-07-06
Product Quantity637 units

Reason for Recall

The blood agar side of the bi-plate may not grow some patient isolates or QC organisms as intended.

Firm Action

The recalling firm issued a recall notification letter dated 12/16/2020 to all impacted customers. The letter states that all impacted product has since expired on 12/10/2020. Customers are asked to review of reported test results should be determined by the appropriate technical expert. Customers are also asked to keep the notification letter on file. The notice should be passed on to all who need to be aware within the organization or to any organization where the potentially affected products have been transferred. Questions may be directed to the Technical Services Department at 1-800-255-6730 (US) or via email: [email protected].

Root Cause

Mixed-up of materials/components

Distribution Pattern

Distribution in United States - AL, FL, GA, LA MS, NC, SC, TN

Official Source

View FDA Recall →

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

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