VACUETTE TUBE 8 ml CAT Serum Separator Clot Activator 16x100 red cap-yellow ring, non-ridged
FDA device recall Z-2375-2024 · posted 2024-07-17 · Open, Classified
Recall details
- Recalling firm
- Greiner Bio-One North America, Inc.
- 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.
- Action taken
- Customers 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.
- Root cause
- Employee error
- Status
- Open, Classified
- Product code
- JKA
- Quantity affected
- 1,008,000pcs (840 cartons)
- Distribution
- Nationwide 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
- Date initiated
- 2024-05-14
- Date posted
- 2024-07-17
- Location
- Monroe, NC
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| VACUETTE BLOOD COLLECTION TUBE WITH CLOT ACTIVATOR AND GEL SEPARATOR (K081929) | Greiner Bio-One North America, Inc. | 2008-12-16 |
| GREINER VACUETTE BLOOD COLLECTION TUBE (K983952) | Greiner Meditech, Inc. | 1998-12-28 |
| GREINER VACUTTE BLOOD COLLECTION TUBE W/ CLOT ACTIVATOR & GEL SEPARATOR (K960858) | Greiner America, Inc. | 1996-08-30 |