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U.S. Department of Health and Human Services

Class 2 Device Recall Quantimetrix Dipper Urinalysis Dipstick control

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 Class 2 Device Recall Quantimetrix Dipper Urinalysis Dipstick controlsee related information
Date Initiated by FirmSeptember 17, 2024
Date PostedOctober 22, 2024
Recall Status1 Open3, Classified
Recall NumberZ-0138-2025
Recall Event ID 95410
510(K)NumberK874890 
Product Classification Urinalysis controls (assayed and unassayed) - Product Code JJW
ProductQuantimetrix 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.
Code Information UDI-DI: 896863002134
Recalling Firm/
Manufacturer		 Mckesson Medical-Surgical Inc. Corporate Office
9954 Maryland Drive
Deep Run Iii Ste. 4000
Richmond VA 23233
For Additional Information ContactRandy King
804-477-2825
Manufacturer 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.
FDA Determined
Cause 2		Packaging process control
ActionMcKesson 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 in Commerce1 BOX
DistributionUS Nationwide distribution in the state of DC.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = JJW
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