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Reagent Test Strips for Blood, Urobilinogen, Bilirubin… recallZ-1834-2024 · Macherey Nagel Gmbh & Co. Kg · initiated Apr 4, 2024

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Macherey Nagel Gmbh & Co. Kg or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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 root cause category: Under Investigation by firm

What the company is doing

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: [email protected] Tel.: +49-(0)2421 969 340, Regulatory contact: Dr. Markus Meusel QAM, Manager Regulatory Affairs Email: [email protected] Tel. +49 (0) 2421 969 210.

Recall details

Recall number
Z-1834-2024
Status
Open, Classified
Initiated by the company
Apr 4, 2024
Posted by the FDA
May 16, 2024
Recalling firm
Macherey Nagel Gmbh & Co. Kg
Quantity
5,200 packages
Product code
JIL
FDA submissions
K991927
Distribution
US Nationwide distribution in the states of CO, FL, IN, NV, TX.

Product description

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 (models, lots, serial numbers)

Product #102-2285, UDI/DI: 00304040001479, LOT 65402.

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Sources and updates

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