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
Reported: May 31, 2023 Initiated: April 17, 2023 #Z-1628-2023
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
Reason for Recall
Potential for both unexpected positive and negative HbA1c results, may result in misdiagnosis
Details
- Recalling Firm
- Ortho-Clinical Diagnostics, Inc.
- Units Affected
- 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
- Location
- Raritan, NJ
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Ortho-Clinical Diagnostics, Inc.. Units affected: 23751.
Why was this product recalled? ▼
Potential for both unexpected positive and negative HbA1c results, may result in misdiagnosis
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 31, 2023. Severity: Moderate. Recall number: Z-1628-2023.
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