Class 2 Device Recall Henry Schein Urispec 11Way

• Date Initiated by Firm: April 04, 2024
• Date Posted: May 16, 2024
• Recall Status: Open, Classified
• Recall Number: Z-1834-2024
• Recall Event ID: 94454
• 510(K)Number: K991927
• Product Classification: Method, enzymatic, glucose (urinary, non-quantitative) - Product Code JIL
• Product: Reagent Test Strips for Blood, Urobilinogen, Bilirubin, Protein, Nitrite, Ketones, Ascorbic Acid, Glucose, pH, Specific Gravity and Leucocytes in Urine by the Dip and Read Technique.
• Code Information: Product #102-2285, UDI/DI: 00304040001479, LOT 65402.
• Recalling Firm/ Manufacturer: Macherey Nagel Gmbh & Co. Kg; Valencienner Str. 11; Duren Germany
• For Additional Information Contact: Dr. Markus Meusel; 49-2421 969 21
• Manufacturer Reason for Recall: The reason for the recall is one of the test pads, for the parameter leukocytes, was missing on some of the test strips. The issue was identified by a consumer by way of a Henry Schein Inc. (HSI) customer complaint. This problem can potentially result in the possibility that the parameter leucocytes (a non-specific marker for urinary track infections and an indicator for inflammatory renal processes) is interpreted instrumentally as a false negative . The following HSI item number and lot number were affected: Urispec¿ 11-Way, #102-2285, LOT 65402.
• FDA Determined Cause: Under Investigation by firm
• Action: On April4, 2024 URGENT FIELD SAFETY NOTICE letters were sent to direct consignees instructing them to do the following: For distributors: 1. The product named in this safety information must not longer be sold. 2. Confirm the receipt of the information with the attached confirmation of receipt form by April 19, 2024. 3. Pass this safety information on to customers of the affected products. 4. Have the receipt of the information confirmed with the attached confirmation of receipt form. Forward the confirmation forms to our attention using the contact information following. For users: 1. If you have a product Urispec¿ 11-Way, #102-2285, LOT 65402, please check if the leucocytes test pad is present before use of the test strips. 2. Pass the information on to other people and departments who may be working with the product Urispec¿ 11-Way, #102-2285, LOT 65402. 3. Confirm the receipt of the information with the attached confirmation of receipt form by April 19, 2024. 4. If your product is affected, please send the product to your local distributor and arrange for replacement or contact MACHEREY-NAGEL directly. Please make sure in your organization that all users of the above products and other persons to be informed become aware of this Urgent Field Safety Notice. Please keep this information at least until all measures have been completed. Contact persons: Contact for sales / marketing: Dr. Sarah Geenen Product Management Rapid Tests Email: sgeenen@mn-net.com Tel.: +49-(0)2421 969 340, Regulatory contact: Dr. Markus Meusel QAM, Manager Regulatory Affairs Email: mmeusel@mn-net.com Tel. +49 (0) 2421 969 210.
• Quantity in Commerce: 5,200 packages
• Distribution: US Nationwide distribution in the states of CO, FL, IN, NV, TX.
• 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.

• 510(K) Database: 510(K)s with Product Code = JIL and Original Applicant = MACHEREY-NAGEL-DUREN