Class 2 Device Recall STATSITE M BHB Test System

• Date Initiated by Firm: October 02, 2023
• Date Posted: December 06, 2023
• Recall Status: Open, Classified
• Recall Number: Z-0490-2024
• Recall Event ID: 93300
• Product Classification: Nitroprusside, ketones (urinary, non-quant.) - Product Code JIN
• Product: STAT-Site M BHB Test Strips, used with STAT-SITE M Beta-HB Meter as an in vitro diagnostic for blood ketone values.
• Code Information: UDI-DI: 00657498000090, Lot/Expiration: 203044/2024-01-31, 209644/2024-06-30
• Recalling Firm/ Manufacturer: Stanbio Laboratory, LP; 1261 N Main St; Boerne TX 78006-3014
• For Additional Information Contact: 830-249-0772
• Manufacturer Reason for Recall: Deterioration in the stability of the Test Strips results in diminished low-range detection capability and inability to meet linearity performance claims. The root cause of the stability deterioration in is identified as the change in material that caused a pH shift in the coating solution resulting in precipitation during coating runs. The device defect can cause false negative results that may lead to a delay in treatment of patients with associated conditions such as diabetic ketoacidosis.
• FDA Determined Cause: Component change control
• Action: On 10/2/23, recall notices were sent to customers who were asked to do the following: 1) Discontinue use, quarantine and dispose of any remaining inventory of the identified affected product/lot(s). 2) Ensure this information is shared with your laboratory staff and other pertinent personnel. 3) If you are a distributor, complete and return the Customer Response Form and forward the recall notification to your customers/end-users without delay for completion and return. 4) If you are the end user in receipt of the recall notification from the distributor, please complete the Customer Response Form and return it to the distributor. 5) If you are an end user in receipt of the recall notification directly from the recalling firm, complete and return the Customer Response Form. 6) If you have supplied the product to another laboratory, provide them a copy of this voluntary recall notification for completion and return notification for the same action. 7) Ensure a copy of this notification is retained as part of your laboratory Quality System records. 8) Complete and return the response form to productsafety@ekfdiagnostics.com Until the investigation is finalized, if you have further questions and/or would like to discuss possible alternative products, please contact Technical Support at; 1-800-531-5535 ext. 128. Monday through Friday, 08:00 to 17:00 (CST).
• Quantity in Commerce: 2,351
• Distribution: Worldwide - US Nationwide distribution including in the states of AZ, RI, MO, UT, AK, LA, TX, OH, GA, MN, NY, CA, NJ, IL, WA, KS, MI, NC, PA, MA, CO, KY, NM, FL, MD, VA, IN, AL, SD, MS, WV, WI, ID, MT, WY and the countries of Canada and Singapore.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.