remel BactiDrop Acridine Orange, REF 21502, 50 per package.
FDA Recall Z-0266-2025 · Posted 2024-10-30
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Recalling FirmRemel, Inc
Recall StatusOpen, Classified
Product CodeJFO
Date Initiated2024-09-20
Product Quantity29 kits
Reason for Recall
A color change of the solution within the dropper can occur from orange-yellow to light yellow resulting in out-of-specification fluorescent stain results.
Firm Action
The recalling firm issued letters dated 9/18/2024 on 9/20/2024 via first class mail. The letter explained the reason for recall, risk to health, product distribution information, and actions to be taken by the consignee, which included destroying any remaining inventory of the affected lot number and completion and return of the Acknowledgement Form indicating the number of units destroyed. The form was to be returned via email. The notice was to be passed onto all who need to be aware within the consignee's organization or to any organization where the affected products have been transferred.
Root Cause
Under Investigation by firm
Distribution Pattern
Distribution was made to IL, IN, MN, NE, SD, TX, VA, and WA. There was government distribution but no military distribution. Foreign distribution was made to the 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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