FDA Medical Device Recalls (openFDA)
Mckesson Medical-Surgical Inc. Corporate Office: 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.
- Recall number
- Z-0138-2025
- Recalling firm
- Mckesson Medical-Surgical Inc. Corporate Office
- 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.
- Status
- Open, Classified
- Initiated
- 2024-09-17
- Posted
- 2024-10-22
- Terminated
- not on file
- Reason
- 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
- Packaging process control
- Action
- 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.
- Quantity
- 1 BOX
- Distribution
- US Nationwide distribution in the state of DC.
- Lot, serial or model codes
- UDI-DI: 896863002134
- 510(k) numbers
- K874890
- PMA numbers
- not on file
- Product code
- JJW
- Firm FEI
- 3004386693
- Firm city
- Richmond
- Firm state
- VA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28