—#210150

Product

Quantimetrix Urine Chemistry Control Set Dipper Urinalysis Dipstick Testing Levels 1 & 2 6 X 15 mL-IVD intended as a control for urinalysis reagent strips, microalbumin, and creatinine by listed test methods.

FDA product code: JJW — Urinalysis Controls (Assayed And Unassayed)
Device class: Class 1
Medical specialty: Clinical Chemistry
510(k) numbers: K874890
Affected lot / code info: UDI-DI: 896863002134

Why it was recalled

The Quantimetrix Dipper Urinalysis Dipstick control was shipped without the validated summer packaging and may have been exposed to temperatures above 25C. This may lead to delay in patients' results.

Root cause (FDA determination)

Packaging process control

Action the firm took

McKesson issued Urgent Product Recall letter via FedEx Overnight service scheduled for delivery on 9/17/24 to one consignee. Letter states reason for recall, health risk and action to take: 1. Immediately examine your inventory and quarantine all product subject to this urgent product recall detailed in the affected products list (Attachment #1). 2. Please complete, sign, and return the enclosed response form (Attachment #2 - Customer Response Form) as soon as possible, even if you do not have any product on hand. Return completed signed form MMSQARecalls@McKesson.com. 3. If you have any product, destroy using your local procedures and document the destruction on attached customer response form (Attachment #2 - Customer Response Form). Return completed signed form MMSQARecalls@McKesson.com. 4. If you have further distributed this product, please notify them immediately of this urgent product recall. You are encouraged to include a copy of this notification letter in your communication. If you have questions regarding this notification, please contact McKesson MedicalSurgical directly by phone at (800) 688-8840. Representatives are available Monday -Friday, 8:00 am - 5:00 pm.

Recalling firm

Firm: Mckesson Medical-Surgical Inc. Corporate Office 9954 Maryland Drive Deep Run Iii Ste. 4000 Richmond VA 23233

Distribution

Distribution pattern: US Nationwide distribution in the state of DC.

Timeline

Recall initiated: 2024-09-17
Posted by FDA: 2024-10-22
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #210150. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.