Recall Z-1729-2015— Ortho-Clinical Diagnostics
Class II · Terminated
Class II FDA medical device recall by Ortho-Clinical Diagnostics, initiated 2015-04-06, terminated 2018-05-25. It names one FDA 510(k) clearance: K063144. Product: Assay Data Disk (ADD), All DRV versions that support product within expiry dating Automates pre-analytical and post-analytical sample and data management for in vitro diagnostic use. VITROS Urine Assays: VITROS Calcium (Ca), Magnesium (Mg), and Phosphorus (Phos) requires acidification pretreatment prior to urine assay testing. Reason: Software anomaly regarding urine samples that require acidified pretreatment. The software has allowed urine samples for assays that require acidified pretreatment to be metered from the same sample container as assays that required no pretreatment when the sample was programmed..
- Recalling firm
- Ortho-Clinical Diagnostics
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-04-06
- Terminated
- 2018-05-25
- 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
Assay Data Disk (ADD), All DRV versions that support product within expiry dating Automates pre-analytical and post-analytical sample and data management for in vitro diagnostic use. VITROS Urine Assays: VITROS Calcium (Ca), Magnesium (Mg), and Phosphorus (Phos) requires acidification pretreatment prior to urine assay testing
Reason for recall
Software anomaly regarding urine samples that require acidified pretreatment. The software has allowed urine samples for assays that require acidified pretreatment to be metered from the same sample container as assays that required no pretreatment when the sample was programmed.
Data sourced from openFDA. This site is unofficial and independent of the FDA.