VACUETTE TUBE 4 ml FX Sodium Fluoride/Potassium Oxalate, Item #454297, 13x75 grey cap-black ring, non-ridged.
- Recall Initiated
- December 12, 2023
- Posted
- January 16, 2024
- Recall Number
- Z-0733-2024
- Quantity
- 495,600 tubes
- Firm Location
- Monroe, NC
Reason for Recall
Tubes have missing additive/anticoagulant resulting in clotting in most cases. A completely clotted sample would lead to no results being reported, which could lead to a delay in treatment or diagnosis. An erroneous glucose or lactose result from a partially clotted sample could lead to inappropriate treatment.
Distribution
US Nationwide distribution in the states of CT, FL, IA, IL, MO, NC, NY, PA, TN, and VA.
Lot / Code Info
Lot #A221135N, Exp. date 03/02/2024, UDI-DI Case label 39120017575130, UDI Rack label 29120017575133.
Root Cause
Software design
Action Taken
Distributors were emailed the notification letter dated 12/11/2023 on 12/12/2023 and the other consignees were sent the letter on 12/13-14/2023 via email or USPS. The distributor letter explained the issue, identified the product, the potential health hazard, informed the consignee they should not use the tubes, and requests use of the product immediately be stopped and the product be isolated in their facility. The consignee should assess the risks and consequences of the use of the defective product in accordance with their procedures and take appropriate action. The enclosed Product Disposition Site Confirmation form is to be returned via email or FAX to confirm the consignee has discarded/destroyed all recalled product in their possession. Distributors were informed that their customers should notified and the letter requests the distributor to provide the recalling firm with a list of their customers who received the product along with the date and quantity that was shipped to the customer. The letter going to other customers provided the same information as the distributor letter except no subrecall information was mentioned within the letter, but the response form requests any facility or location to whom the tubes were forwarded should be advised of the recall and the names of those facilities/locations were to be provided to the recalling firm.