Recall Z-1834-2024 ยท JIL Method, Enzymatic, Glucose (Urinary, Non-Quantitative)
Macherey Nagel Gmbh & Co. Kg
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.
| Date | May 16, 2024 (initiated Apr 4, 2024) |
| Status | Open, Classified |
| 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 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. |
| Root 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 |
| Quantity | 5,200 packages |
| Distribution | US Nationwide distribution in the states of CO, FL, IN, NV, TX. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K991927 | MEDI-TEST COMBI 11 Macherey-Nagel-Duren, Sep 17, 1999 |