Blastomyces dermatitidis Antiserum 1 mL vial GIBSON… recallZ-0606-2018 · Gibson Laboratories LLC · initiated Jan 20, 2017
Class II Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Gibson Laboratories LLC or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
The firm information that the product was reporting false positive results
FDA root cause category: Mixed-up of materials/components
What the company is doing
On January 20, 2017, the firm sent Urgent Medical Device Recall notification letter and response form to their customers. The letter identified the affected and the reason for the recall. Users are instructed not to use any Blastomyces dermatitidis (catalog # 200265) that they may have in inventory and to quarantine any affected product. Return any affected product per the instructions provided; and, complete and return the attached acknowledgement form. Questions regarding this recall should be directed to Penny Epperson, Quality Manager, at 859-303-5169 or [email protected].
Recall details
- Recall number
- Z-0606-2018
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Jan 20, 2017
- Recalling firm
- Gibson Laboratories LLC
- Quantity
- 10/1 mL vials
- Product code
- LSI
- Distribution
- Distributed to the states of AL, AZ & MS.
Product description
Blastomyces dermatitidis Antiserum 1 mL vial GIBSON BIOSCIENCE. Catalog 200265 Intended for identification of the systemic fungal pathogens.
Code information (models, lots, serial numbers)
Lot # 5072543 Exp Date 03/12/2021; UDI : 10634853000039.
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Fungal Serology 200265Microbiologics Inc. · Antiserum, Blastomyces Dermatitidis, Other1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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