PlainRecalls
FDA Devices Moderate Class II Terminated

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

Reported: June 17, 2015 Initiated: April 6, 2015 #Z-1729-2015

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.

Details

Units Affected
2,387 units Total (987 domestically & 1400 internationally)
Distribution
Worldwide Distribution - US Nationwide, Brazil, Chile, Mexico, Australia, Hong Kong, India, Taiwan, Belgium, Denmark, France, Ireland, Italy, Portugal, Romania, Spain, Sweden and the UK.
Location
Rochester, NY

Frequently Asked Questions

What product was recalled? ▼
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. Recalled by Ortho-Clinical Diagnostics. Units affected: 2,387 units Total (987 domestically & 1400 internationally).
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 17, 2015. Severity: Moderate. Recall number: Z-1729-2015.

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