VITROS recallZ-1628-2023 · Ortho-Clinical Diagnostics, Inc. · initiated Apr 17, 2023

Why it was recalled

Potential for both unexpected positive and negative HbA1c results, may result in misdiagnosis

FDA root cause category: Under Investigation by firm

What the company is doing

Ortho Clinical Diagnostics (Ortho) issued to Dealers and End-Users Urgent Product Correction Notification Potential Bias Observed in VITROS Chemistry Products HbA1c Reagent Kit on 4/17/23. Letter states reason for recall, health risk and action to take: In an abundance of caution, the required actions are applicable to all lots within expiry ( as well as future lots until your laboratory receives an additional notification from Ortho. However, while data is limited, a review of the release testing indicated no other lots were impacted. Reagent Pack Used for Calibration o If your system currently has multiple HbA1c reagent packs, leave one reagent pack on the system and unload all other reagent packs and store at 2-8 oC (36-46 oF) until needed. o Calibrate the one HbA1c reagent pack on your system. o Perform QC after successful calibration. QC must be acceptable and subsequently performed every 8 hours of testing, for the first 2 days that the reagent pack is onboard the system. o If QC fails with a negative bias, troubleshoot according to your laboratory s procedure. o If QC fails with a positive bias, load a new pack and re-calibrate following the required actions. Review the patient results since the last passing QC by your Medical Director. o After 2 days of passing within your laboratory s established QC range, performing QC every 8 hours is no longer necessary on that pack. Refer to Testing section below for QC requirements after calibration. Reagent Pack Loading Only have one reagent pack loaded onboard your VITROS System at a time. " Reagent Pack Used for Testing o Once the reagent pack used for calibration is depleted, QC must be performed upon loading each reagent pack and must be within the laboratory s established QC range prior to patient testing. o If the QC results are outside your laboratory s established range with a negative bias, then discard that reagent pack and load a new pack to perform QC again. o Ortho s observed data does not demonstrate

Recall details

Recall number

Z-1628-2023

Status

Open, Classified

Initiated by the company

Apr 17, 2023

Posted by the FDA

May 24, 2023

Recalling firm

Ortho-Clinical Diagnostics, Inc.

Quantity

23751

Product code

PDJ

FDA submissions

K142595

Distribution

US Nationwide- Worldwide Distribution. Foreign: Australia Belgium Brazil Bermuda HM12 Canada L3R 4G5 Chile China Colombia Denmark France France Germany India Italy Japan Mexico Norway Portugal Russia Singapore 609917 Spain Sweden The Netherlands United Kingdom

Product description

VITROS Chemistry Products HbA1c Reagent Kit- IVD for the quantitative determination of percent glycated hemoglobin A1c (DCCT/NGSP) and mmol/mol hemoglobin A1c (IFCC) in human whole blood. Product Code: 6842905

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

• VITROS 6842905

  Ortho-Clinical Diagnostics, Inc. · Hemoglobin A1c test system
  1 recall21 reports

Product lines

• VITROSOrtho-Clinical Diagnostics, Inc. · 71 models · 806 reports · 96 recalls