Recall Z-0069-2027 ยท OIE Urine Collection Kit (Excludes Hiv Testing)
Medical Action Industries, Inc. 306
Generic Name: Kit, Urine, Clean Catch Trade Name: Kit: Urinary Clean Catch 20/cs Model/Catalog Number: 76769 Lot Number: 333606 UDI-DI: 20809160118228 Software Version: N/A
| Date | Oct 2, 2026 (initiated Jul 9, 2026) |
| Status | Open, Classified |
| Reason | An internal data-entry error caused kit lot 333606 to be labeled with an expiration date of March 31, 2027, instead of February 28, 2027. |
| Root cause | Labeling design |
| Action | On 07/09/2026, an "URGENT: MEDICAL DEVICE FIELD CORRECTION" Letter was emailed to customers informing them that, due to an internal error, item 76769, KIT: Urinary Clean Catch, was inadvertently assigned an incorrect expiration date of 2027/03/31. The correct expiration date is 2027/02/28. Product was distributed between 09/24/2025 to 12/17/2025. On 08/03/2026, an updated "URGENT: MEDICAL DEVICE FIELD CORRECTION" letter was emailed to customer to notify them that, The previous notifications, dated July 9, 2026 and July 24, 2026, contained an incorrect lot number. As stated below, the correct |
| Quantity | 4000 |
| Distribution | U.S.: CA O.U.S.: N/A |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.