RecallDepth

greiner bio-one VACUETTE TUBE 6 ml K3E K3EDTA, 13x100 pink cap-black ring, non-ridged, 24 racks of 50 pcs., 1200 pcs in total, Item #456003

Company
Greiner Bio-One North America, Inc.
Recall Initiated
March 31, 2023
Posted
May 12, 2023
Recall Number
Z-1583-2023
Quantity
36,000 pieces (30 full cases)
Firm Location
Monroe, NC

Reason for Recall

Some of the tubes may be incorrectly labeled.

Distribution

US Nationwide distribution in the states of WI and GA.

Lot / Code Info

Lot #B220533J, Exp. 2023-10-31, UDI Case label (01)39120017576496(17)231031(10)B220533J, UDI Rack label 29120017576499(17)231031(10)B220533J.

Root Cause

Labeling Change Control

Action Taken

The recalling firm issued a letter dated 3/30/2023 on 3/31/2023 via email to their sole customer. The letter provided the reason for recall, contained detailed information regarding the complaint, provided photographs of the product which included incorrect tube labels and correct tube labels, investigation results, health risk analysis, and actions to be taken. Those actions included to discontinue use of the product immediately and isolate it, assess the risks and consequences of the use of the defective product in accordance with the customer's procedures and take appropriate action, and complete the attached Product Disposition Site Confirmation. The customer is to record the amount of product they have destroyed on the form and return it via FAX or email. It also instructs that if the customer has distributed this product elsewhere, they are requested to provide the recalling firm with the contact information for follow-up.

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