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 Recall Z-0138-2025 · Posted 2024-10-22
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Recalling FirmMckesson Medical-Surgical Inc. Corporate Office
Recall StatusOpen, Classified
Product CodeJJW
Date Initiated2024-09-17
Product Quantity1 BOX
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.
Firm 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 [email protected].
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 [email protected].
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
Distribution Pattern
US Nationwide distribution in the state of DC.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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