Recall Z-3184-2018— Ortho-Clinical Diagnostics

Name: FDA recall Z-3184-2018
Creator: U.S. Food and Drug Administration
Published: 2018-07-11

Class III · Terminated

Class III FDA medical device recall by Ortho-Clinical Diagnostics, initiated 2018-07-11, terminated 2020-08-11. It names one FDA 510(k) clearance: K162020. Product: VITROS Chemistry Products Cl- Slides, Product Code 684 4471 Product Usage: VITROS Cl Slides (Product Code 684 4471) - For in vitro diagnostic use only. VITROS Chemistry Products Cl- Slides quantitatively measure chloride (Cl-) concentration in serum, plasma and urine using VITROS 250/350/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System. Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis.. Reason: The slides failed to meet current claims for Limit of Blank (LoB), Limit of Detection (LoD) and Limit of Quantification (LoQ) for urine samples. The measuring range (15-300 mmol/L) for urine samples when tested with the Cl- slide is not affected. The current Cl- LoQ is 5 mmol/L and the LoQ determined by this investigation is 15 mmol/L..

Recalling firm: Ortho-Clinical Diagnostics
Classification: Class III
Status: Terminated
Initiated: 2018-07-11
Terminated: 2020-08-11
Firm location: Rochester, NY, United States

510(k) clearances named in this recall

1 on FDA's record

K162020 — VITROS Chemistry Products Cl- SlidesOrtho Clinical Diagnostics·cleared 2016-12-16

K-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 Cl- Slides, Product Code 684 4471 Product Usage: VITROS Cl Slides (Product Code 684 4471) - For in vitro diagnostic use only. VITROS Chemistry Products Cl- Slides quantitatively measure chloride (Cl-) concentration in serum, plasma and urine using VITROS 250/350/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System. Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis.

Reason for recall

The slides failed to meet current claims for Limit of Blank (LoB), Limit of Detection (LoD) and Limit of Quantification (LoQ) for urine samples. The measuring range (15-300 mmol/L) for urine samples when tested with the Cl- slide is not affected. The current Cl- LoQ is 5 mmol/L and the LoQ determined by this investigation is 15 mmol/L.

Data sourced from openFDA. This site is unofficial and independent of the FDA.