MAUDE Adverse Event Report: BIO SB, INC CD45 (2B11 & PD7/26); IMMUNOHISTOCHEMISTRY REAGENTS AND KITS

Catalog Number	BSB 5251
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 cd45 (2b11 & pd7/26) 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 2b11 and pd7/26, but only one was confirmed in the affected lots.Although no adverse health consequences were reported, the potential for diagnostic misinterpretation exists.

• Brand Name: CD45 (2B11 & PD7/26)
• Common Device Name: IMMUNOHISTOCHEMISTRY REAGENTS AND KITS
• Manufacturer (Section D): BIO SB, INC; 5385 hollister avenue; bldg 8, suite108; 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, suite108; santa barbara, CA ; 8005611145
• MDR Report Key: 22041562
• Report Number: 3008773547-2025-00002
• Device Sequence Number: 21057611
• Product Code: NJT
• UDI-Device Identifier: B502BSB52510
• UDI-Public: B502BSB52510
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Risk Manager
• 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 5251
• Device Lot Number: 5251OOI27
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• 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: 02/01/2024
• 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