VACUETTE TUBE, 3.5mL CAL Serum Sep Clot Activator, REF 454067P - Product Usage: VACUETTE Tubes, Holders, and Needles are use together as a system for the collection of venous blood. VACUETTE tubes are used to collect, transport, and process blood for testing serum, plasma, or whole blood in the clinical laboratory.
FDA Recall Z-0818-2020 · Posted None
Advertisement
Recalling FirmGreiner Bio-One North America, Inc.
Recall StatusTerminated
Product CodeJKA
Date Initiated2019-11-25
Date Terminated2020-10-05
Product Quantity1,002,000 tubes
Reason for Recall
The Vacuette 3.5mL Serup Sep Clot Activator Tubes may have been damaged at the cap sealing area. This may lead to a vacuum loss and tubes not filling up to the proper volume.
Firm Action
The firm initiated the recall by email on 11/25/2019. The letter explained the problem and requested the consignees cease distribution and provide a list of their customers for Greiner to contact. The firm is seeking return or on site destruction of the affected product.
Root Cause
Process control
Distribution Pattern
Nationwide distribution in the states of IL, MO, AZ, NC. PA, UT, NY, ME, PR, VA, PA
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
Advertisement