Recall Z-1152-2013— Ortho-Clinical Diagnostics
Class II · Terminated
Class II FDA medical device recall by Ortho-Clinical Diagnostics, initiated 2013-03-14, terminated 2015-06-23. It names one FDA 510(k) clearance: K984288. Product: VITROS Chemistry Products PHBR (Phenobarbital) Slides, REF 822 1384. For the quantitative measure of phenobarbital (PHBR) concentration in serum and plasma.. Reason: Ortho Clinical Diagnostics (OCD) received customer complaints of intermittent imprecision, outliers, or shifts in accuracy and control fluid values outside of expected intervals when using VITROS Chemistry Products PHBR Slides. OCD's investigation confirmed that positively biased values for patient samples could be obtained that may not be detected by quality control fluids..
- Recalling firm
- Ortho-Clinical Diagnostics
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2013-03-14
- Terminated
- 2015-06-23
- Firm location
- Rochester, NY, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
VITROS Chemistry Products PHBR (Phenobarbital) Slides, REF 822 1384. For the quantitative measure of phenobarbital (PHBR) concentration in serum and plasma.
Reason for recall
Ortho Clinical Diagnostics (OCD) received customer complaints of intermittent imprecision, outliers, or shifts in accuracy and control fluid values outside of expected intervals when using VITROS Chemistry Products PHBR Slides. OCD's investigation confirmed that positively biased values for patient samples could be obtained that may not be detected by quality control fluids.
Data sourced from openFDA. This site is unofficial and independent of the FDA.