MAUDE Adverse Event Report: BIO SB, INC MITF (C5 & D5); IMMUNOHISTOCHEMISTRY REAGENTS AND KITS

Catalog Number	BSB 6252
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/03/2024
Type of Reportable Event	Malfunction
Event or Problem Description
A customer complaint was received regarding mitf (c5 & d5) antibody cocktail performance in ihc staining.Internal investigation revealed that certain lots were missing one of the labeled clones, which may lead to false-negative results.The product labeling indicates the presence of both clones c5 and d5, but only one was confirmed in the affected lots.Although no adverse health consequences were reported, the potential for diagnostic misinterpretation exists.

• Brand Name: MITF (C5 & D5)
• Common Device Name: IMMUNOHISTOCHEMISTRY REAGENTS AND KITS
• Manufacturer (Section D): BIO SB, INC; 5385 hollister avenue; bldg 8, #108; santa barbara CA 93111
• Manufacturer (Section G): BIO SB, INC; 5385 hollister avenue; bldg 8, suite 108; santa barbara CA 93111
• Manufacturer Contact: jessica dunston ; 5385 hollister avenue; bldg 8, #108; santa barbara, CA 93111 ; 8005611145
• MDR Report Key: 22041563
• Report Number: 3008773547-2025-00001
• Device Sequence Number: 8899090
• Product Code: NJT
• UDI-Device Identifier: B502BSB62520
• UDI-Public: B502BSB62520
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 05/18/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: BSB 6252
• Device Lot Number: 6252OOI13
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/27/2024
• Initial Report FDA Received Date: 05/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/31/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown