All recalls8,504 total
Product may be contaminated with Listeria monocytogenes.
Potential presence of Listeria monocytogenes.
Potential presence of Listeria monocytogenes.
Test strips and other tests including for near-patient testing, that require a 510(k) were distributed before they could be legally marketed to U.S. customers; devices may cause false or inaccurate diagnostic result by lay person and lead to inappropriate medical intervention.
Test strips and other tests including for near-patient testing, that require a 510(k) were distributed before they could be legally marketed to U.S. customers; devices may cause false or inaccurate diagnostic result by lay person and lead to inappropriate medical intervention.
Test strips and other tests including for near-patient testing, that require a 510(k) were distributed before they could be legally marketed to U.S. customers; devices may cause false or inaccurate diagnostic result by lay person and lead to inappropriate medical intervention.
Test strips and other tests including for near-patient testing, that require a 510(k) were distributed before they could be legally marketed to U.S. customers; devices may cause false or inaccurate diagnostic result by lay person and lead to inappropriate medical intervention.
Test strips and other tests including for near-patient testing, that require a 510(k) were distributed before they could be legally marketed to U.S. customers; devices may cause false or inaccurate diagnostic result by lay person and lead to inappropriate medical intervention.
Test strips and other tests including for near-patient testing, that require a 510(k) were distributed before they could be legally marketed to U.S. customers; devices may cause false or inaccurate diagnostic result by lay person and lead to inappropriate medical intervention.
Test strips and other tests including for near-patient testing, that require a 510(k) were distributed before they could be legally marketed to U.S. customers; devices may cause false or inaccurate diagnostic result by lay person and lead to inappropriate medical intervention.
Test strips and other tests including for near-patient testing, that require a 510(k) were distributed before they could be legally marketed to U.S. customers; devices may cause false or inaccurate diagnostic result by lay person and lead to inappropriate medical intervention.
Test strips and other tests including for near-patient testing, that require a 510(k) were distributed before they could be legally marketed to U.S. customers; devices may cause false or inaccurate diagnostic result by lay person and lead to inappropriate medical intervention.
Test strips and other tests including for near-patient testing, that require a 510(k) were distributed before they could be legally marketed to U.S. customers; devices may cause false or inaccurate diagnostic result by lay person and lead to inappropriate medical intervention.
Test strips and other tests including for near-patient testing, that require a 510(k) were distributed before they could be legally marketed to U.S. customers; devices may cause false or inaccurate diagnostic result by lay person and lead to inappropriate medical intervention.
Potential contamination with Salmonella.
Potential contamination with leachable lead.
Product tested positive for Listeria Monocytogenes.
Potential contamination with leachable lead.
Product tested positive for Listeria Monocytogenes.
The products contain an unallowed color Carmoisine (E122) - Acid Red 14.
Potential contamination with leachable lead.
Potential contamination with leachable lead.
Product tested positive for Listeria Monocytogenes.
The products contain an unallowed color Carmoisine (E122) - Acid Red 14.
Product tested positive for Listeria Monocytogenes.
The products contain an unallowed color Carmoisine (E122) - Acid Red 14.
Product tested positive for Listeria Monocytogenes.
Product tested positive for Listeria Monocytogenes.
Product tested positive for Listeria Monocytogenes.
Product tested positive for Listeria Monocytogenes.
Cross Contamination with Other Products: Testing of reserve samples showed presence of traces of ezetimibe
Emphasizing instructions for LVP duration programming located in the IFU.
Issues identified: 1) Results vary by Instrument Platform; 2) Calibrator Lot-to-Lot Variability. Issues may lead to delayed or incorrect diagnosis, as well as delay of treatment or incorrect treatment.
Firm received multiple complaints regarding tubing disconnecting from oxygen mask. If issue occurs during use, may lead to delay in patient care and patient may experience shortness of breath leading to hypoxia, which may require medical intervention to prevent further respiratory deterioration.
Product may be contaminated with Salmonella
Unapproved drug claims on product labeling and product misbranded due to no Supplement Facts label
Unapproved drug claims on product labeling and product misbranded due to no Supplement Facts label
Unapproved drug claims on product labeling and product misbranded due to no Supplement Facts label
Unapproved drug claims on product labeling and product misbranded due to no Supplement Facts label
Unapproved drug claims on product labeling and product misbranded due to no Supplement Facts label
Unapproved drug claims on product labeling and product misbranded due to no Supplement Facts label
Unapproved drug claims on product labeling and product misbranded due to no Supplement Facts label
Unapproved drug claims on product labeling and product misbranded due to no Supplement Facts label
Unapproved drug claims on product labeling and product misbranded due to no Supplement Facts label
Incorrect Product Formulation
Automated Dispensing Cabinets (ADC) received a Half Height CUBIE drawer firmware update, which caused a Cubie Insert event which prompts software to generate a duplicate address, which causes an error and the drawer to fail, which may lead to inability or delay in accessing stored items, delay in the replenishment of ADCs or patient specific medications stored outside of ADCs.
Software issue where a Device Reset message displayed on the app was unable to be cleared. In rare cases, this resulted in an inability to resume therapy, and the patient experienced a recurrence of underlying pain symptoms. Resolution would require surgical replacement of the INS.
Products found to contain leachable lead levels (3.00 mg/L)