Reagent Test Strips for Blood, Urobilinogen, Bilirubin, Protein, Nitrite, Ketones, Ascorbic Acid, Glucose, pH, Specific
Summary
The FDA issued a Class II for Reagent Test Strips for Blood, Urobilinogen, Bilirubin, Protein, Nitrite, Ketone by Macherey Nagel Gmbh & Co. Kg. Reason: 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.
Details
Source
Device Recall
External ID
Z-1834-2024
Action Date
2024-05-22
Status
Ongoing
Category
device
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.
Lot/Code Info: Product #102-2285, UDI/DI: 00304040001479, LOT 65402.
Quantity Affected: 5,200 packages
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.
Distribution
US Nationwide distribution in the states of CO, FL, IN, NV, TX.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-04-04
Company
Duren, N/A
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 191 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Macherey Nagel Gmbh & Co. Kg) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Macherey Nagel Gmbh & Co. Kg have FDA actions?
This is the only FDA action we have on record for Macherey Nagel Gmbh & Co. Kg in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1834-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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