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U.S. Department of Health and Human Services

Class 2 Device Recall Ortho Clinical Diagnostics

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  Class 2 Device Recall Ortho Clinical Diagnostics see related information
Date Initiated by Firm April 17, 2023
Date Posted May 24, 2023
Recall Status1 Open3, Classified
Recall Number Z-1628-2023
Recall Event ID 92254
510(K)Number K142595  
Product Classification Hemoglobin A1c test system - Product Code PDJ
Product 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
Code Information UDI-DI: 10758750030729 Lot Number/Expiry: 29-9396 2023-SEP-02; 29-9466 2023-SEP-02; 30-9647 2023-NOV-25; 30-9803 2023-NOV-25; 31-9648 2024-JAN-24; 32-9925 2024-APR-14; 33-1097 2024-JUL-18; 33-1105 2024-JUL-18; 33-1228 2024-JUL-18; 34-1345* 2024-OCT-17. All lots within expiry (listed above) as well as future lots until your laboratory receives an additional notification from Ortho
Recalling Firm/
Manufacturer		 Ortho-Clinical Diagnostics, Inc.
1001 Us Highway 202
Raritan NJ 08869-1424
For Additional Information Contact SAME
908-218-8776
Manufacturer Reason
for Recall		 Potential for both unexpected positive and negative HbA1c results, may result in misdiagnosis
FDA Determined
Cause 2		 Under Investigation by firm
Action 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
Quantity in Commerce 23751
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
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = PDJ and Original Applicant = ORTHO CLINICAL DIAGNOSTICS
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