FDA-Device2026-10-14Class IIIMISBRANDING
Medical Action Industries urinary clean-catch kit recalled for incorrect expiration date labeling
What this means
A data-entry error caused one lot of Medical Action Industries' urinary clean-catch collection kits to be labeled with an expiration date of March 31, 2027, when the correct date is February 28, 2027. This means the kits could be used beyond their intended shelf life, potentially affecting test reliability.
- Check if you have lot 333606 (labeled 3/31/2027) of the urinary clean-catch kit, model 76769.
- Do not use kits from this lot after February 28, 2027.
- Contact your supplier or Medical Action Industries for a replacement or guidance.
The agency's original wording
Hazard
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.
Intended for
All ages
Illnesses reported
None reported
Sold states
U.S.: CA O.U.S.: N/A
Affected count
4000
Manufactured in
25 Heywood Rd, N/A, Arden, NC, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0069-2027More Medical Action Industries recalls
- FDA-Device2026-09-23Medical Action Industries blood culture kits recalled for compromised sterile packaging
- FDA-Device2026-09-16Medical Action Industries epidural/pain kit recalled for compromised sterility
- FDA-Device2026-09-16Medical Action Industries epidural kits recalled for potentially compromised sterility
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