Quantimetrix Urine Chemistry Control Set Dipper Urinalysis Dipstick Testing Levels 1 & 2 6 X 15 mL-IVD intended as a con

FDA device recall Z-0138-2025 · posted 2024-10-22 · Open, Classified

Recall details

Recalling firm

Mckesson Medical-Surgical Inc. Corporate Office

Reason for recall

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.

Action taken

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.

Root cause

Packaging process control

Status

Open, Classified

Product code

JJW

Quantity affected

1 BOX

Distribution

US Nationwide distribution in the state of DC.

Date initiated

2024-09-17

Date posted

2024-10-22

Location

Richmond, VA

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