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U.S. Department of Health and Human Services

Class 2 Device Recall VACUETTE 5 ml CAT Serum Clot Activator

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 Class 2 Device Recall VACUETTE 5 ml CAT Serum Clot Activatorsee related information
Date Initiated by FirmAugust 28, 2020
Create DateSeptember 29, 2020
Recall Status1 Terminated 3 on June 17, 2021
Recall NumberZ-3027-2020
Recall Event ID 86363
510(K)NumberK081929 
Product Classification Tubes, vials, systems, serum separators, blood collection - Product Code JKA
ProductVACUETTE TUBE 5 mL CAT Serum Separator Clot Activator, Item Number: 456018P - Product Usage: are used to collect, transport, and process blood for testing serum, plasma or whole blood in the clinical laboratory.
Code Information Lot Number: B2003399
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		Blood collection tubes experienced an issue with separation and clotting
FDA Determined
Cause 2		Under Investigation by firm
ActionGreiner Bio-One North America issued an urgent product recall notification on August 28, 2020. It state the following: 1. Stop distributing the mentioned product (concerned item/lot) immediately and isolate defective products in your facility. 2. Complete the Product Disposition form and fax it to Greiner at 800.726.0052 or email to patech@gbo.com. 3. Greiner will contact you for the return or destruction of the product after receiving the attached Product Disposition Site Confirmation form. Greiner will also use this information to send you replacement stock or issue a credit. 4. Please provide Greiner with a list of your customers that have received the item with this specific lot number. Include: Facility, Address, Key contact, Phone number, Fax, and Date shipped. Please provide this as an Excel file preferably. If this is not possible, please forward the information in any format. If you have additional questions, please call Greiner Technical Service at 800-515-8112.
Quantity in Commerce1,008,000 pieces
DistributionUS Nationwide distribution including in the states of IL, PA, VA, MO, NY.
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = JKA
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