Z-0606-2018Class II

Blastomyces dermatitidis Antiserum 1 mL vial GIBSON BIOSCIENCE. Catalog 200265 Intended for identification of...

Name: Z-0606-2018 Blastomyces dermatitidis Antiserum 1 mL vial GIBSON BIOSCIENCE. Catalog 200265 Intended for identification of...
Creator: Gibson Laboratories LLC
Published: 2017-01-20
License: https://open.fda.gov/license/

Microbiologics, Inc. / initiated 2017-01-20 / Terminated

FDA source

Gibson Laboratories LLC began a recall of Blastomyces dermatitidis Antiserum 1 mL vial GIBSON BIOSCIENCE. Catalog 200265 Intended for identification of the systemic fungal pathogens on 2017-01-20. FDA classified it as Class II and gives the reason as "The firm information that the product was reporting false positive results". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0606-2018
Classification: Class II
Status: Terminated
Initiated: 2017-01-20
Posted: 2018-02-14
Terminated: 2018-02-20
Recalling firm: Microbiologics, Inc.
Product: Blastomyces dermatitidis Antiserum 1 mL vial GIBSON BIOSCIENCE. Catalog 200265 Intended for identification of the systemic fungal pathogens.
Product code: LSI Antiserum, Blastomyces Dermatitidis, Other
Reason for recall: The firm information that the product was reporting false positive results
FDA root cause: Mixed-up of materials/components
Action: 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].
Quantity in commerce: 10/1 mL vials
Distribution: Distributed to the states of AL, AZ & MS.
Product codes and lots: Lot # 5072543 Exp Date 03/12/2021; UDI : 10634853000039.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0606-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0606-2018	Class II	Terminated	Voluntary: Firm initiated	2018-02-21	2018-02-13

Product code LSI

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)