The Food and Drug Administration (FDA) warns all healthcare professionals on the voluntary recall of the following BD Microtainer® blood collection tubes manufactured by BD Caribe:
|Product Name||Product Code||Lot Number|
|BD Microtainer® Capillary Blood Collection Tube with K2EDTA-Tube Micro w/ Microgard EDTA LAV||21041362||8243545|
|BD Microtainer® Z Capillary Blood Collection Tube (No Additives)- Tube Micro w/ Microgard PLN RD||21041356||8223778|
BD Microtainer® SST Capillary Blood Collection Tube-Tube Micro w/ Microgard SST GLD
|BD Microtainer® Amber Capillary Blood Collection Tube-Tube Micro w/ Microgard SST GLD/AMB||21041358||8233967|
BD is conducting a voluntary recall for the aforementioned BD Microtainer® products based on the confirmation that these products may have damaged tube reservoirs.
A damaged reserviors may caused insufficient blood sample collection and non-proportional blood-to-additive ratio, hence producing inaccurate results. Moreover, a patient may be required to undergo a repeat blood sample collection and testing on the event that any of theaforementioned BD Microtainer® with damaged reservoir was used during blood collection.
In light of the foregoing, all concerned healthcare professionals, and establishments is warned to discontinue further use, sale, and distribution of the medical device.
All FDA Regional Field Offices and Regulatory Enforcement Units, in coordination with law enforcement agencies and Local Government Units, are requested to ensure that these health products are not sold or made available in the market or areas of jurisdiction.
To report any sale or distribution of unregistered medical device, the online reporting facility, eReport can be accessed at www.fda.gov.ph/ereport.
Any suspected adverse reaction experienced from the use of the medical device but not limited to the lot numbers stated above should be reported immediately to FDA.
For more information and inquiries, kindly contact the FDA Center for Device Regulation, Radiation Health, and Research through e-mail at [email protected], or call (02) 857-1900 loc. 8301.
Dissemination of this advisory to all concerned is hereby requested.
Attachment:-> FDA Advisory No. 2019-393