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U.S. Department of Health and Human Services

Class 2 Device Recall VACUETTE TUBE 8 ml CAT Serum Separator Clot Activator

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 Class 2 Device Recall VACUETTE TUBE 8 ml CAT Serum Separator Clot Activatorsee related information
Date Initiated by FirmMay 14, 2024
Date PostedJuly 17, 2024
Recall Status1 Open3, Classified
Recall NumberZ-2375-2024
Recall Event ID 94817
510(K)NumberK081929 K960858 K983952 
Product Classification Tubes, vials, systems, serum separators, blood collection - Product Code JKA
ProductVACUETTE TUBE 8 ml CAT Serum Separator Clot Activator 16x100 red cap-yellow ring, non-ridged
Code Information Item Number: 455071P; UDI Case label: 39120017573068; UDI Rack label: 29120017573061; Lot Number: B24013MV
Recalling Firm/
Manufacturer		 Greiner Bio-One North America, Inc.
4238 Capital Dr
Monroe NC 28110-7681
For Additional Information ContactKevin Daugherty
704-261-7800
Manufacturer Reason
for Recall		The firm received reports that some blood collection tubes have experienced issues with clotting and poor separation due to missing additive. The failure of the device would likely require sample recollection which could result in a delay of treatment.
FDA Determined
Cause 2		Employee error
ActionCustomers were notified of the recall beginning on 05/14/2024 via emailed "Urgent Product Recall" letter. Distributors were also notified of the recall on 05/14/2024 via UPS, email and phone. The customers and Distributors were instructed to 1. Stop using the product (concerned Item/Lot) immediately and isolate defective products in the facility; 2. Assess the risks and consequences of the use of this defective product in accordance with procedures and take appropriate action; 3. Complete the attached Product Disposition Site Confirmation form and fax to Greiner Bio-One North America, Inc. at 877-217-7927 or email to recalls.us@gbo.com. This form is to confirm that you have discarded/destroyed all products from this Item/Lot. Greiner will replace the product upon receipt of your completed form. Greiner will contact the distributor for the return of the product after receiving the attached Product Disposition Site Confirmation form. They will also use this information to issue a credit. If you have additional questions, please call Greiner Technical Service at 704-220-1664.
Quantity in Commerce1,008,000pcs (840 cartons)
DistributionNationwide Distribution to states of: AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WV and WY.
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 = JKA
510(K)s with Product Code = JKA
510(K)s with Product Code = JKA
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